drugset
drugset / Trial / NCT02282813

Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

NCT02282813 ↗

Phase 3 Completed 298 enrolled OPKO Health, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in stage 3 or 4 chronic kidney disease patients.

Timeline

Start
2013-04
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Calcifediol Unknown 30 ug Oral
Subject Calcifediol Unknown 60 ug Oral
Subject Calcitriol Small molecule 0.25 ug Oral
Subject Doxercalciferol Small molecule 0.5 ug Oral
Subject Paricalcitol Other / unclassified 1 ug Oral

Indications

chronic kidney disease secondary hyperparathyroidism of renal origin vitamin D deficiency