| Trial ID: | L1016 |
| Source ID: | NCT05543928
|
| Associated Drug: |
Ctap101
|
| Title: |
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
|
| Acronym: |
|
| Status: |
TERMINATED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Chronic Kidney Disease stage3|Chronic Kidney Disease stage4|Vitamin d Deficiency|Secondary Hyperparathyroidism
|
| Interventions: |
DRUG: CTAP101|DRUG: Placebo
|
| Outcome Measures: |
Primary: Numbers of subjects who attained mean decrease in plasma iPTH of 30% from baseline, The primary efficacy endpoint is the proportion of subjects in the intent-to- treat (ITT) population (age 8 to \<18 years) attaining a mean decrease in plasma iPTH of at least 30% from pre-treatment baseline compared to placebo during the EAP., 26 weeks|Safety and tolerability, Safety and tolerability will be evaluated in the safety population by AEs, PEs, VS, hematology and laboratory evaluations, and ECGs., 26 weeks|Pharmacokinetic, To assess the pharmacokinetic (PK) profile of 25-hydroxyvitamin D3 after repeated doses of CTAP101 Capsules in pediatric subjects, 26 weeks | Secondary: Level of serum total 25-hydroxyvitamin D at ≥30 ng/mL compared to placebo, To evaluate the efficacy of repeated dosing with CTAP101 Capsules versus placebo in raising serum total 25-hydroxyvitamin D to ≥30 ng/mL, 26 weeks|Plasma iPTH mean absolute changes and serum total 25-hydroxyvitamin D, To determine the time courses of mean absolute changes from pre-treatment baseline in serum total 25-hydroxyvitamin D and plasma iPTH during administration of repeated doses of CTAP101 Capsules, 26 weeks|Pharmacodynamic effects of repeated doses of CTAP101 Capsules, To assess the PD effects of repeated doses of CTAP101 Capsules versus placebo on mean serum calcium (corrected for albumin), serum phosphorus and serum calcium-timesphosphorus (CaxP) product, and the change in mean urine calcium:creatinine ratio, 26 weeks|Incidence of hypercalcemia and hyperphosphatemia, To evaluate the safety of CTAP101 Capsules versus placebo with regard to the incidence of hypercalcemia and hyperphosphatemia, 26 weeks
|
| Sponsor/Collaborators: |
Sponsor: OPKO Health, Inc.
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE3
|
| Enrollment: |
2
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2023-01-31
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| Completion Date: |
2024-06-19
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| Results First Posted: |
|
| Last Update Posted: |
2024-07-25
|
| Locations: |
Nationwide Childrens Hospital, Columbus, Ohio, 43205, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05543928
|
