Trial Outcomes & Findings for Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 (NCT NCT02282813)
NCT ID: NCT02282813
Last Updated: 2016-09-29
Results Overview
Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
298 participants
Primary outcome timeframe
up to 6 months
Results posted on
2016-09-29
Participant Flow
Subjects could enroll in extension study after completing trials CTAP101-CL-3001 or CTAP101-CL-3002. Subjects from 68 sites participated with at least 1 subject enrolled in the extension per site. Three sites participated in both blinded trials.
Treatment groups were categorized as treated for 26 weeks; subjects previously on placebo in predecessor trials) or 12 months (52 weeks; subjects previously on active treatment in predecessor trials). Following 12 weeks, a subset of eligible subjects (n=up to 90) could be randomized to take adjunctive therapy in addition to CTAP101 capsules.
Participant milestones
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
|---|---|---|---|
|
Overall Study
STARTED
|
103
|
153
|
42
|
|
Overall Study
COMPLETED
|
91
|
130
|
39
|
|
Overall Study
NOT COMPLETED
|
12
|
23
|
3
|
Reasons for withdrawal
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
0
|
|
Overall Study
Adverse Event
|
3
|
10
|
1
|
|
Overall Study
Subject non-compliance
|
1
|
4
|
0
|
|
Overall Study
Physician Decision
|
0
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
|
Overall Study
Serum Ca >/=11.0mg/dL
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
|
Overall Study
Administrative reasons
|
0
|
1
|
0
|
Baseline Characteristics
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
Baseline characteristics by cohort
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
n=103 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Monotherapy; 12 Mos Treatment)
n=153 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
n=42 Participants
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
Total
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 10.78 • n=99 Participants
|
66.9 years
STANDARD_DEVIATION 9.83 • n=107 Participants
|
65.0 years
STANDARD_DEVIATION 12.34 • n=206 Participants
|
65.9 years
STANDARD_DEVIATION 10.56 • n=7 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
154 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
144 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=99 Participants
|
153 participants
n=107 Participants
|
42 participants
n=206 Participants
|
298 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsPopulation: Intent to treat
Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders
Outcome measures
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
n=103 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
n=153 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
n=42 Participants
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
|---|---|---|---|
|
Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)
|
34 participants
|
66 participants
|
30 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Per protocol
Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders
Outcome measures
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
n=91 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
n=126 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
n=40 Participants
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
|---|---|---|---|
|
Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)
|
34 participants
|
64 participants
|
29 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Intent to treat
Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D \>/= 30 ng/mL at End of Treatment (EOT)
Outcome measures
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
n=103 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
n=153 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
n=42 Participants
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
|---|---|---|---|
|
Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)
|
87 participants
|
124 participants
|
38 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsPopulation: Per protocol
Number of Participants in the per protocol population with serum 25-hydroxyvitamin D \>/= 30 ng/mL at End of Treatment (EOT)
Outcome measures
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
n=91 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
n=126 Participants
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
n=40 Participants
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
|---|---|---|---|
|
Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)
|
86 participants
|
120 participants
|
37 participants
|
Adverse Events
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
Serious events: 18 serious events
Other events: 36 other events
Deaths: 0 deaths
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
Serious events: 33 serious events
Other events: 54 other events
Deaths: 0 deaths
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
Serious events: 9 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
n=103 participants at risk
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
n=153 participants at risk
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
n=42 participants at risk
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Cardiac failure congestive
|
2.9%
3/103 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Acute myocardial infarction
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Cardiac arrest
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
General disorders
Chest pain
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
General disorders
Asthenia
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Pneumonia
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
2.0%
3/153 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Cellulitis
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Sepsis
|
1.9%
2/103 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Urinary tract infection
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Bronchitis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Enterococcal
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Eschericia infection
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Eschericia sepsis
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Septic shock
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Sinusitis
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Wound infection
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Injury, poisoning and procedural complications
Tibia
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Investigations
Blood creatinine increased
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Investigations
Blood creatinine phosphokinase MB increased
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Diabetes with hyperosmolarity
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Basal ganglia inferction
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Convulsion
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Presyncope
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Syncope
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Nervous system disorders
Hypoglcaemic seizure
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Psychiatric disorders
Mental status changes
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Renal and urinary disorders
Renal failure acute
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
2/103 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Vascular disorders
Deep vein thrombosis
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Vascular disorders
Hypertension
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.65%
1/153 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/103 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
Other adverse events
| Measure |
CTAP101 Capsules (Not Randomized; 6 Mos Treatment)
n=103 participants at risk
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.
|
CTAP101 Capsules (Not Randomized; 12 Mos Treatment)
n=153 participants at risk
CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.
CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily
|
CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive
n=42 participants at risk
CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.8%
7/103 • Number of events 7 • 6 months from initiation of treatment through end of treatment
|
5.9%
9/153 • Number of events 9 • 6 months from initiation of treatment through end of treatment
|
4.8%
2/42 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
|
Gastrointestinal disorders
Constipation
|
6.8%
7/103 • Number of events 7 • 6 months from initiation of treatment through end of treatment
|
3.9%
6/153 • Number of events 6 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
7/103 • Number of events 7 • 6 months from initiation of treatment through end of treatment
|
3.9%
6/153 • Number of events 6 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Gastrointestinal disorders
Nausea
|
7.8%
8/103 • Number of events 8 • 6 months from initiation of treatment through end of treatment
|
3.3%
5/153 • Number of events 5 • 6 months from initiation of treatment through end of treatment
|
4.8%
2/42 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
|
General disorders
Oedema peripheral
|
5.8%
6/103 • Number of events 6 • 6 months from initiation of treatment through end of treatment
|
3.3%
5/153 • Number of events 5 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/42 • 6 months from initiation of treatment through end of treatment
|
|
General disorders
Fatigue
|
6.8%
7/103 • Number of events 7 • 6 months from initiation of treatment through end of treatment
|
2.0%
3/153 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Infections and infestations
Urinary tract obstruction
|
1.9%
2/103 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
6.5%
10/153 • Number of events 10 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Gout
|
6.8%
7/103 • Number of events 7 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
2.4%
1/42 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
|
General disorders
Oedema
|
1.9%
2/103 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
1.3%
2/153 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
7.1%
3/42 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
|
Investigations
Blood creatinine increased
|
2.9%
3/103 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
3.9%
6/153 • Number of events 6 • 6 months from initiation of treatment through end of treatment
|
7.1%
3/42 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
1.9%
2/103 • Number of events 2 • 6 months from initiation of treatment through end of treatment
|
2.0%
3/153 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
9.5%
4/42 • Number of events 4 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
2.0%
3/153 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
7.1%
3/42 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.97%
1/103 • Number of events 1 • 6 months from initiation of treatment through end of treatment
|
0.00%
0/153 • 6 months from initiation of treatment through end of treatment
|
7.1%
3/42 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
5/103 • Number of events 5 • 6 months from initiation of treatment through end of treatment
|
2.6%
4/153 • Number of events 4 • 6 months from initiation of treatment through end of treatment
|
7.1%
3/42 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
|
Vascular disorders
Hypertension
|
3.9%
4/103 • Number of events 4 • 6 months from initiation of treatment through end of treatment
|
3.9%
6/153 • Number of events 6 • 6 months from initiation of treatment through end of treatment
|
7.1%
3/42 • Number of events 3 • 6 months from initiation of treatment through end of treatment
|
Additional Information
Douglass Laidlaw, PhD, Vice President, Medical Affairs
OPKO Health, Inc.
Phone: 305-575-4172
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60