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A Randomized, Double Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects With Chronic Kidney Disease, Vitamin D Insufficiency and Secondary Hyperparathyroidism
This study will investigate how the levels of a repeat dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with chronic kidney disease (CKD, vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
Details
| Lead sponsor | OPKO Health, Inc. |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | COMPLETED |
| Enrolment | 78 |
| Start date | 2010-10 |
| Completion | 2011-11 |
Conditions
- Chronic Kidney Disease
- Secondary Hyperparathyroidism
- Vitamin D Insufficiency
Interventions
- Cohort 1 CTAP101 Capsules- 60µg
- Cohort 1 CTAP101 Capsules - 90µg
- Cohort 1 Matching Sugar Capsule
- Cohort 2 CTAP101 Capsules - 30µg
- Cohort 2 Matching Sugar Capsule
Primary outcomes
- Proportion (%) of Subjects With Serum 25-hydroxyvitamin D ≥30 ng/mL (PP). — 6 weeks
The proportion of subjects in the per protocol population with serum 25-hydroxyvitamin D ≥30 ng/mL at End-of-Treatment (EOT; Week 6) in Cohorts 1 and 2 (60/90 and 30 μg groups, respectively) were compared to their corresponding placebo groups. - Mean Percent Change From Baseline in Plasma Intact Parathyroid Hormone (iPTH) to End of Treatment (Per Protocol Population) — 6 weeks
Mean percent change from baseline in plasma intact parathyroid hormone (iPTH) from baseline to End of Treatment (EOT) in the Per Protocol population. Subjects in Cohorts 1 and 2 (dose regimens 60/90 and 30 mcg, respectively) were compared to their respective placebo groups.
Countries
United States