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
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
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
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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