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

NCT02282813 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 298

Last updated 2016-09-29

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Joel Melnick, MD · OPKO Renal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

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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 NCT02282813 on ClinicalTrials.gov