NCT02282813

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: OPKO Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Only subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 are eligible to participate in this extension study. This is a phase 3, open-label study of CTAP101 Capsules, with and without add-on vitamin D hormone therapy.

Conditions

• Chronic Kidney Disease
• Hyperparathyroidism, Secondary
• Vitamin D Deficiency

Interventions

Type	Name	Description
DRUG	CTAP101 Capsules	At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily
DRUG	Calcitriol	At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily
DRUG	Doxercalciferol	At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily
DRUG	Paricalcitol	At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-11-04
• Last updated: 2016-09-29
• Results posted: 2016-08-17