NCT01704079

Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of CTAP101 Capsules to Treat Secondary Hyperparathyroidism in Subjects With Stage 3 or 4 Chronic Kidney Disease and Vitamin D Insufficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: OPKO IP Holdings II, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and tolerability of CTAP101 will also be evaluated

Detailed description

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of CTAP101 Capsules administered for 26 weeks to treat SHPT in subjects ≥18 years of age with stage 3 or 4 CKD and vitamin D insufficiency. The study will be conducted at approximately 40 sites within the United States (US). Approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by CKD stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either CTAP101 Capsules or matching placebo. An Interactive Voice Response System (IVRS) will provide study treatment group assignments using the computer-generated randomization code provided by the IVRS vendor. Subjects will receive an initial daily dose of 1 capsule (CTAP101 Capsules, 30 µg, or matching placebo) for the first 12 weeks. After l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the IVRS with oversight by an independent medical monitor.

Conditions

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

Interventions

Type	Name	Description
DRUG	CTAP101 30 μg capsules	CTAP101 30 μg capsule taken daily at bedtime
OTHER	Sugar pill to CTAP101 30 μg capsules	Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-08-01
• Completion: 2014-09-01
• First posted: 2012-10-11
• Last updated: 2025-01-13
• Results posted: 2016-08-17

Locations

1 site across 1 country: United States