CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 298 enrolled
Drug / intervention
CTAP101 Capsules +3 moredrug
Likely dose
CTAP101 Capsules 30 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02282813
NCT02282813Phase 3Completed
CompareCT.gov

A Long-term Safety and Efficacy Study of CTAP101 Capsules in Subjects With Stages 3 or 4 Chronic Kidney Disease, Secondary Hyperparathyroidism and Vitamin D Insufficiency (Extension of Study CTAP101-CL-3001 or CTAP101-CL-3002)

OPKO Health, Inc.·interventional·Posted Nov 4, 2014·Updated Sep 29, 2016

In Brief

A Phase 3 clinical trial evaluating CTAP101 Capsules, Calcitriol, and 2 other interventions for Chronic Kidney Disease and 2 related conditions. Completed, enrolled 298 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2014
Enrollment StartApr 1, 2013
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.7 years ago

Interventions

CTAP101 Capsulesdrug

At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily

Calcitrioldrug

At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily

Doxercalciferoldrug

At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily

Paricalcitoldrug

At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily