Trial Outcomes & Findings for Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis (NCT NCT02859896)
NCT ID: NCT02859896
Last Updated: 2026-07-02
Results Overview
Blood samples were collected for assessment of iPTH levels. The percentage of participants meeting the iPTH \>=30% reduction from baseline at 2 consecutive study visits up to Week 12 was calculated. Two consecutive \>=30% reductions in iPTH from baseline up to Week 12 was defined as two consecutive 30% or greater reductions at any two consecutive measurements from baseline up to Week 12 with on-treatment strategy applied. The confidence interval (CI) was estimated using Clopper-Pearson method. The baseline value is defined as the last available value before the first dose of study treatment. Percentages are rounded off to the tenth decimal place.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
21 participants
Primary outcome timeframe
Baseline (Day 1) up to Week 12
Results posted on
2026-07-02
Participant Flow
The study was conducted at 23 centers in 2 countries. A total of 59 participants were screened from 19 January 2017 to 05 February 2020, of which 38 were screen failures. Screen failures were mainly due to participants did not meet the inclusion/exclusion criteria of the study.
A total of 21 participants were randomized in a 2:1 ratio to receive either doxercalciferol (Hectorol®) or calcitriol (Rocaltrol®). The study was conducted to fulfill a post-marketing commitment (PMC). The study was terminated as food and drug administration (FDA) acknowledged the fulfillment of this PMC on 11 June 2025. Note: Reason for not completed = Reason for permanent treatment discontinuation.
Participant milestones
| Measure |
Doxercalciferol (Hectorol®)
Participants were administered doxercalciferol (Hectorol®) one 0.5 microgram (μg) capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's intact parathyroid hormone (iPTH) management.
|
Calcitriol (Rocaltrol®)
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
7
|
|
Overall Study
COMPLETED
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Doxercalciferol (Hectorol®)
Participants were administered doxercalciferol (Hectorol®) one 0.5 microgram (μg) capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's intact parathyroid hormone (iPTH) management.
|
Calcitriol (Rocaltrol®)
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Overall Study
Other
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Baseline characteristics by cohort
| Measure |
Doxercalciferol (Hectorol®)
n=14 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
n=7 Participants
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.9 years
STANDARD_DEVIATION 4.0 • n=20 Participants
|
10.4 years
STANDARD_DEVIATION 4.7 • n=20 Participants
|
11.4 years
STANDARD_DEVIATION 4.2 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White/Black or African American
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Week 12Population: Full analysis set (FAS) consisted of all treated participants with at least 2 assessments of iPTH after use of study treatment.
Blood samples were collected for assessment of iPTH levels. The percentage of participants meeting the iPTH \>=30% reduction from baseline at 2 consecutive study visits up to Week 12 was calculated. Two consecutive \>=30% reductions in iPTH from baseline up to Week 12 was defined as two consecutive 30% or greater reductions at any two consecutive measurements from baseline up to Week 12 with on-treatment strategy applied. The confidence interval (CI) was estimated using Clopper-Pearson method. The baseline value is defined as the last available value before the first dose of study treatment. Percentages are rounded off to the tenth decimal place.
Outcome measures
| Measure |
Doxercalciferol (Hectorol®)
n=14 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
n=7 Participants
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Percentage of Participants Who Achieved 2 Consecutive >=30% Reductions in Intact Parathyroid Hormone From Baseline up to Week 12
|
14.3 percentage of participants
Interval 1.78 to 42.81
|
71.4 percentage of participants
Interval 29.04 to 96.33
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to Weeks 12 and 24Population: FAS consisted of all treated participants with at least 2 assessments of iPTH after use of study treatment.
Blood samples were collected for assessment of iPTH levels. The percentage changes from baseline iPTH, the effects over the treatment period time was explored using a mixed model for repeated measures approach (MMRM) as appropriate. The baseline value is defined as the last available value before the first dose of study treatment.
Outcome measures
| Measure |
Doxercalciferol (Hectorol®)
n=14 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
n=7 Participants
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Percent Change in Intact Parathyroid Hormone From Baseline to Weeks 12 and 24
Week 12
|
14.85 percent change
Standard Error 12.37
|
-17.76 percent change
Standard Error 17.15
|
|
Percent Change in Intact Parathyroid Hormone From Baseline to Weeks 12 and 24
Week 24
|
18.85 percent change
Standard Error 17.60
|
-52.72 percent change
Standard Error 24.80
|
SECONDARY outcome
Timeframe: Up to Weeks 12 and 24Population: FAS consisted of all treated participants with at least 2 assessments of iPTH after use of study treatment.
Hypercalcemia was defined as albumin corrected serum calcium \>10.2 milligrams per deciliter (mg/dL). Here, data for number of hypercalcemia events are reported.
Outcome measures
| Measure |
Doxercalciferol (Hectorol®)
n=14 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
n=7 Participants
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Number of Hypercalcemia Events up to Weeks 12 and 24
Week 12
|
1 hypercalcemia events
|
0 hypercalcemia events
|
|
Number of Hypercalcemia Events up to Weeks 12 and 24
Week 24
|
1 hypercalcemia events
|
0 hypercalcemia events
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeksPopulation: Safety population consisted of all randomized participants who had taken at least one dose of study treatment.
An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, and which did not necessarily have a causal relationship with this treatment. An AE occurred or was detected from the date the participant signed the informed consent form, irrespective of study periods without administration of the study treatment. TEAEs were defined as the AEs that developed, worsened or became serious during the treatment-emergent period (defined as time from administration of study treatment \[Day 1\] to last administration of study treatment + 4 days). SAE: Any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Outcome measures
| Measure |
Doxercalciferol (Hectorol®)
n=14 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
n=7 Participants
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
11 Participants
|
6 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10Population: PK population consisted of doxercalciferol (Hectorol®) participants in the safety population with at least one post-dose, non-missing concentration value. Only participants with data collected at specified timepoints are reported.
Blood samples were collected at specified timepoints after administration of doxercalciferol (Hectorol®) to determine Cmax. Evaluation of the 1, 25-Dihydroxyvitamin D2 concentration-time data was obtained using non-compartmental methods. As pre-specified in protocol pharmacokinetic (PK) parameters were assessed at Week 8 or Week 10 choice was as per the schedule availability of the site and the participants.
Outcome measures
| Measure |
Doxercalciferol (Hectorol®)
n=5 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
|
27.2 picograms per milliliter (pg/mL)
Standard Deviation 18.9
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10Population: PK population consisted of doxercalciferol (Hectorol®) participants in the safety population with at least one post-dose, non-missing concentration value. Only participants with data collected at specified timepoints are reported.
Blood samples were collected at specified timepoints after administration of doxercalciferol (Hectorol®) to determine tmax. Evaluation of the 1, 25-Dihydroxyvitamin D2 concentration-time data was obtained using non-compartmental methods. As pre-specified in protocol PK parameters were assessed at Week 8 or Week 10 choice was as per the schedule availability of the site and the participants.
Outcome measures
| Measure |
Doxercalciferol (Hectorol®)
n=5 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Time to Maximum Plasma Concentration (Tmax) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
|
1.07 hours
Interval 0.0 to 7.75
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10Population: PK population consisted of doxercalciferol (Hectorol®) participants in the safety population with at least one post-dose, non-missing concentration value. Only participants with data collected at specified timepoints are reported.
Blood samples were collected at specified timepoints after administration of doxercalciferol (Hectorol®) to determine AUC0-24h. Evaluation of the 1, 25-Dihydroxyvitamin D2 concentration-time data was obtained using non-compartmental methods. As pre-specified in protocol PK parameters were assessed at Week 8 or Week 10 choice was as per the schedule availability of the site and the participants.
Outcome measures
| Measure |
Doxercalciferol (Hectorol®)
n=5 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24h) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
|
595 hours*pg/mL
Standard Deviation 422
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 1, 4, 7, and 24 hours post-dose at Week 8 or 10Population: PK population consisted of doxercalciferol (Hectorol®) participants in the safety population with at least one post-dose, non-missing concentration value. Only participants with data collected at specified timepoints are reported.
Blood samples were collected at specified timepoints after administration of doxercalciferol (Hectorol®) to determine Ctrough. Evaluation of the 1, 25-Dihydroxyvitamin D2 concentration-time data was obtained using non-compartmental methods. As pre-specified in protocol PK parameters were assessed at Week 8 or Week 10 choice was as per the schedule availability of the site and the participants.
Outcome measures
| Measure |
Doxercalciferol (Hectorol®)
n=4 Participants
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Trough Plasma Concentration (Ctrough) of 1,25-Dihydroxyvitamin D2 at Week 8 or 10
|
18.6 pg/mL
Standard Deviation 7.40
|
—
|
Adverse Events
Doxercalciferol (Hectorol®)
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Calcitriol (Rocaltrol®)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxercalciferol (Hectorol®)
n=14 participants at risk
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
n=7 participants at risk
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Vascular disorders
Hypertensive Urgency
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Renal and urinary disorders
End Stage Renal Disease
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
Other adverse events
| Measure |
Doxercalciferol (Hectorol®)
n=14 participants at risk
Participants were administered doxercalciferol (Hectorol®) one 0.5 μg capsule orally two to three times weekly depending on participants age until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
Calcitriol (Rocaltrol®)
n=7 participants at risk
Participants were administered calcitriol (Rocaltrol®) one 0.25 μg capsule per day orally seven days a week from Day 1 until Week 24. A dose titration scheme was used to individualize the dose to participant's iPTH management.
|
|---|---|---|
|
Infections and infestations
Giardiasis
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Otitis Media Acute
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Tinea Versicolour
|
7.1%
1/14 • Number of events 2 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 2 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
28.6%
2/7 • Number of events 3 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Eye disorders
Periorbital Swelling
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • Number of events 3 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • Number of events 4 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
28.6%
2/7 • Number of events 2 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 2 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Renal and urinary disorders
Nephropathy
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Renal and urinary disorders
Proteinuria
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
28.6%
2/7 • Number of events 2 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Investigations
Adjusted Calcium Increased
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Investigations
Blood Parathyroid Hormone Decreased
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Investigations
Blood Phosphorus Increased
|
14.3%
2/14 • Number of events 3 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 2 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Infections and infestations
Cystitis
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Investigations
Body Temperature Increased
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
7.1%
1/14 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
0.00%
0/7 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
|
Injury, poisoning and procedural complications
Stoma Site Haemorrhage
|
0.00%
0/14 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
14.3%
1/7 • Number of events 1 • Adverse events collected from first dose of study treatment (Day 1) up to 4 days after the last dose of study treatment; approximately 36 weeks. All-cause mortality (death) was assessed from signing of the informed consent form to end of follow-up for each participant, approximately 224.57 weeks.
Analysis was performed on the safety population.
|
Additional Information
Trial Transparency Team
Sanofi aventis recherche & développement
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER