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

NCT01651000 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2025-01-13

Study results available
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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

Conditions

Interventions

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.

Sponsors & Collaborators

  • OPKO IP Holdings II, Inc.

    lead INDUSTRY

Principal Investigators

  • Joel Melnick, MD · Opko Renal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01651000 on ClinicalTrials.gov