Chronic Kidney Disease Stage 3 and 4 Clinical Trial
Official title:
A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 Years With Moderate to Severe Chronic Kidney Disease
Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg
paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney
disease (CKD Stages 3 and 4).
Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo
in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with
moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study
drug followed by a minimum of 12 weeks of open-label active drug.
The study consists of two parts. Part 1 is an open-label single-dose, non-fasting, multicenter study to evaluate the pharmacokinetics (PK) of paricalcitol capsules in 12 children ages 10 to 16 years with CKD Stages 3 and 4. Part 2 of this study will be conducted as a 12 week randomized double-blind, placebo-controlled study, followed by 12 weeks open-label treatment. Participants active or enrolled under amendment 5 will enter a follow-up period and have study visits every 4 weeks until the final participant reaches Week 24. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01173848 -
Vitamin D Supplement Study for Stage Three and Four Chronic Kidney Disease (CKD) Patients
|
Phase 3 |