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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02282813
Recruitment Status : Completed
First Posted : November 4, 2014
Results First Posted : August 17, 2016
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hyperparathyroidism, Secondary Vitamin D Deficiency Drug: CTAP101 Capsules Drug: Calcitriol Drug: Doxercalciferol Drug: Paricalcitol Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : April 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Calcifediol

Drug: Calcitriol
At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily
Other Name: 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 Name: Calcifediol

Drug: Doxercalciferol
At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily
Other Name: 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 Name: Calcifediol

Drug: Paricalcitol
At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily
Other Name: calcifediol


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02282813


Sponsors and Collaborators
OPKO Health, Inc.
Investigators
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Study Director: Joel Melnick, MD OPKO Renal
More Information
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Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT02282813    
Other Study ID Numbers: CTAP101-CL-3003
First Posted: November 4, 2014    Key Record Dates
Results First Posted: August 17, 2016
Last Update Posted: September 29, 2016
Last Verified: August 2016
Keywords provided by OPKO Health, Inc.:
Parathyroid Diseases
Renal Insufficiency
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Vitamin D
 Hyperparathyroidism
Kidney Diseases
Kidney Failure
Renal Insufficiency, Chronic
Additional relevant MeSH terms:
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Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Vitamin D Deficiency
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Parathyroid Diseases
Endocrine System Diseases
Calcitriol
Calcifediol
1 alpha-hydroxyergocalciferol
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Bone Density Conservation Agents