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

August 22, 2016 updated by: OPKO Health, Inc.

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completed either of the phase 3 double-blind, placebo-controlled studies, CTAP101-CL-3001 or CTAP101-CL-3002
  • Taking no more than 1000 mg/day of elemental Ca and willing/able to remain on this dose for the duration of the study
  • Taking no more than 1600 IU/dose vitamin D (ergocalciferol or cholecalciferol) therapy and willing/able to remain on a stable dose of vitamin D during the study
  • Willing and able to comply with study instructions and to commit to all clinic visits for the duration of the study
  • Female subjects of childbearing potential must be neither pregnant nor lactating and must have a negative urine pregnancy test
  • All female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective contraception (eg, implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study
  • Have the ability to read and understand subject Informed Consent Form (ICF). Subjects or their legal representatives must sign the ICF.

Exclusion Criteria:

  • Use of pharmacological dose of ergocalciferol and cholecalciferol (monthly equivalent of 50,000 IU or 1250 µg, eg, Drisdol®) or bisphosphonate therapy
  • Use of other bone metabolism therapy (with the exception of stable doses of bisphosphonates and denosumab [Xgeva® and Prolia®]) that may interfere with study endpoints
  • Concomitant serious illness or medical condition, such as malignancy, human immunodeficiency virus, significant gastrointestinal or hepatic disease or cardiovascular event or hepatitis that in the opinion of the investigator may worsen and/or interfere with participation in the study
  • Neurological/psychiatric disorder, including psychotic disorder or dementia, or any condition reason which, in the opinion of the investigator makes adherence to a treatment or follow-up schedule unlikely
  • Known or suspected hypersensitivity to any of the constituents of either investigational product (CTAP101) or adjunctive vitamin D hormone therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTAP101 Capsules alone
CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks
Drug: CTAP101 Capsules
At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily
Other Names:
  • Calcifediol
Experimental: CTAP101 Capsules +calcitriol
CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks
Drug: CTAP101 Capsules
At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily
Other Names:
  • Calcifediol
Drug: Calcitriol
At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily
Other Names:
  • calcifediol
Experimental: CTAP101 Capsules +doxercalciferol
CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks
Drug: CTAP101 Capsules
At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily
Other Names:
  • Calcifediol
Drug: Doxercalciferol
At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily
Other Names:
  • calcifediol
Experimental: CTAP101 Capsules +paricalcitol
CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks
Drug: CTAP101 Capsules
At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily
Other Names:
  • Calcifediol
Drug: Paricalcitol
At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily
Other Names:
  • calcifediol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in the Intent to Treat Population With a Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)
Time Frame: up to 6 months
Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants in the Per Protocol Population With Mean Reduction in Plasma Intact Parathyroid Hormone (iPTH) of >/= 30% From Baseline Values at End of Treatment (EOT)
Time Frame: up to 6 months
Number of subjects in the per protocol population with a mean reduction in plasma intact parathyroid hormone (iPTH) of >/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders
up to 6 months
Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)
Time Frame: up to 6 months
Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)
up to 6 months
Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)
Time Frame: up to 6 months
Number of Participants in the per protocol population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OPKO Health, Inc.

Investigators

  • Study Director: Joel Melnick, MD, OPKO Renal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTAP101-CL-3003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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