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

Primary Purpose

Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CTAP101 Capsules
Calcitriol
Doxercalciferol
Paricalcitol
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure, Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    CTAP101 Capsules alone

    CTAP101 Capsules +calcitriol

    CTAP101 Capsules +doxercalciferol

    CTAP101 Capsules +paricalcitol

    Arm Description

    CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks

    CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks

    CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks

    CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks

    Outcomes

    Primary Outcome Measures

    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)
    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

    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)
    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
    Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)
    Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)
    Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)
    Number of Participants in the per protocol population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)

    Full Information

    First Posted
    October 31, 2014
    Last Updated
    August 22, 2016
    Sponsor
    OPKO Health, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02282813
    Brief Title
    Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    May 2015 (Actual)
    Study Completion Date
    May 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    OPKO Health, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease, Hyperparathyroidism, Secondary, Vitamin D Deficiency
    Keywords
    Parathyroid Diseases, Renal Insufficiency, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D, Hyperparathyroidism, Kidney Diseases, Kidney Failure, Renal Insufficiency, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    298 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CTAP101 Capsules alone
    Arm Type
    Experimental
    Arm Description
    CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks
    Arm Title
    CTAP101 Capsules +calcitriol
    Arm Type
    Experimental
    Arm Description
    CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks
    Arm Title
    CTAP101 Capsules +doxercalciferol
    Arm Type
    Experimental
    Arm Description
    CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks
    Arm Title
    CTAP101 Capsules +paricalcitol
    Arm Type
    Experimental
    Arm Description
    CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    CTAP101 Capsules
    Other Intervention Name(s)
    Calcifediol
    Intervention Description
    At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily
    Intervention Type
    Drug
    Intervention Name(s)
    Calcitriol
    Other Intervention Name(s)
    calcifediol
    Intervention Description
    At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily
    Intervention Type
    Drug
    Intervention Name(s)
    Doxercalciferol
    Other Intervention Name(s)
    calcifediol
    Intervention Description
    At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily
    Intervention Type
    Drug
    Intervention Name(s)
    Paricalcitol
    Other Intervention Name(s)
    calcifediol
    Intervention Description
    At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily
    Primary Outcome Measure Information:
    Title
    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)
    Description
    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
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    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)
    Description
    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
    Time Frame
    up to 6 months
    Title
    Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)
    Description
    Number of Participants in the Intent to Treat Population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)
    Time Frame
    up to 6 months
    Title
    Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)
    Description
    Number of Participants in the per protocol population with serum 25-hydroxyvitamin D >/= 30 ng/mL at End of Treatment (EOT)
    Time Frame
    up to 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joel Melnick, MD
    Organizational Affiliation
    OPKO Renal
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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