Trial Outcomes & Findings for A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD) (NCT NCT04064827)
NCT ID: NCT04064827
Last Updated: 2026-06-15
Results Overview
Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
2 participants
Primary outcome timeframe
Up to Week 12
Results posted on
2026-06-15
Participant Flow
Participant milestones
| Measure |
Participants Receiving Paricalcitol
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
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|---|---|
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Overall Study
STARTED
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2
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Overall Study
Dosing Period 1
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2
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Overall Study
Dosing Period 2
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1
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Overall Study
COMPLETED
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1
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
Participants Receiving Paricalcitol
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
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|---|---|
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Overall Study
iPTH levels too high
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1
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Baseline Characteristics
A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)
Baseline characteristics by cohort
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
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|---|---|
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Age, Customized
< 2 years
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0 Participants
n=20 Participants
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Age, Customized
2 to 9 years
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2 Participants
n=20 Participants
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Sex: Female, Male
Female
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1 Participants
n=20 Participants
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Sex: Female, Male
Male
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1 Participants
n=20 Participants
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|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=20 Participants
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|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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1 Participants
n=20 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=20 Participants
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|
Race (NIH/OMB)
Asian
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
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2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=20 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: Up to Week 12Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
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|---|---|
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Percentage of Participants Who Achieve Positive Response During Dosing Period 1
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100 percentage of participants
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PRIMARY outcome
Timeframe: Up to Week 12Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
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|---|---|
|
Incidence of Hypercalcemia During Dosing Period 1
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0 Participants
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SECONDARY outcome
Timeframe: Week 12 through Week 24Population: One subject prematurely discontinued during Period 1.
Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=1 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
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|---|---|
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Percentage of Participants Who Achieve a Positive Response During Dosing Period 2
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100 percentage of participants
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SECONDARY outcome
Timeframe: Up to Week 24Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined
|
100 percentage of participants
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SECONDARY outcome
Timeframe: Up to Week 12Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1
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100 percentage of participants
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SECONDARY outcome
Timeframe: Week 12 through Week 24Population: One subject prematurely discontinued during Period 1.
Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=1 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2
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100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 12Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 1
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12 through Week 24Population: One subject prematurely discontinued during Period 1.
Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=1 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 2
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Periods 1 and 2 Combined
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12 through Week 24Population: One subject prematurely discontinued during Period 1.
Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=1 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Incidence of Hypercalcemia During Dosing Period 2
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0 Participants
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SECONDARY outcome
Timeframe: Up to Week 24Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Outcome measures
| Measure |
Participants Receiving Paricalcitol
n=2 Participants
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
|
|---|---|
|
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined
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0 Participants
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Adverse Events
Participants Receiving Paricalcitol
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants Receiving Paricalcitol
n=2 participants at risk
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
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|---|---|
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Infections and infestations
DEVICE RELATED BACTERAEMIA
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50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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Infections and infestations
DEVICE RELATED INFECTION
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50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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Metabolism and nutrition disorders
HYPERNATRAEMIA
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50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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Nervous system disorders
TONIC CONVULSION
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50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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Other adverse events
| Measure |
Participants Receiving Paricalcitol
n=2 participants at risk
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks Paricalcitol: Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
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|---|---|
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Gastrointestinal disorders
GASTROINTESTINAL INFLAMMATION
|
50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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Infections and infestations
PERITONITIS
|
50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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Respiratory, thoracic and mediastinal disorders
ASTHMA
|
50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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Skin and subcutaneous tissue disorders
VANCOMYCIN INFUSION REACTION
|
50.0%
1/2 • Number of events 1 • All-cause mortality and adverse event tables include AEs reported from the time of informed consent and treatment-emergent events reported from the time of study drug administration to the end of the study. The median time on follow-up was 146 days for participants receiving paricalcitol.
One subject prematurely discontinued during Period 1. None of the SAEs were related to study drug.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place