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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

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

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

NCT ID

NCT02282813

First Posted

October 31, 2014

Last Updated

August 22, 2016

Sponsor

OPKO Health, Inc.

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

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

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

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

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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