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

Phase 3

Completed

Conditions: Chronic Kidney Disease
Hyperparathyroidism, Secondary
Vitamin D Deficiency

Interventions: Drug: CTAP101 Capsules
Drug: Calcitriol
Drug: Doxercalciferol
Drug: Paricalcitol

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
CTAP101 Capsules alone	CTAP101 Capsules	CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks
CTAP101 Capsules +calcitriol	CTAP101 Capsules	CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks
CTAP101 Capsules +calcitriol	Calcitriol	CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks
CTAP101 Capsules +doxercalciferol	Doxercalciferol	CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks
CTAP101 Capsules +doxercalciferol	CTAP101 Capsules	CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks
CTAP101 Capsules +paricalcitol	CTAP101 Capsules	CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks
CTAP101 Capsules +paricalcitol	Paricalcitol	CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks

Primary Outcome Measures

Name	Time	Method
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)	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

Name	Time	Method
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)	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
Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)	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)
Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)	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)