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

OPKO Health

Status and phase: Completed; Phase 3

Conditions: Hyperparathyroidism, Secondary; Chronic Kidney Disease; Vitamin D Deficiency

Treatments: Drug: CTAP101 Capsules; Drug: Doxercalciferol; Drug: Paricalcitol; Drug: Calcitriol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02282813

CTAP101-CL-3003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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298 participants in 4 patient groups

CTAP101 Capsules alone

Experimental group

Description:

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

Treatment:

Drug: CTAP101 Capsules

CTAP101 Capsules +calcitriol

Experimental group

Description:

CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks

Treatment:

Drug: Calcitriol

Drug: CTAP101 Capsules

CTAP101 Capsules +doxercalciferol

Experimental group

Description:

CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks

Treatment:

Drug: Doxercalciferol

Drug: CTAP101 Capsules

CTAP101 Capsules +paricalcitol

Experimental group

Description:

CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks

Treatment:

Drug: Paricalcitol

Drug: CTAP101 Capsules