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

Chronic Kidney Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282813
• Other study ID #: CTAP101-CL-3003
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2014
• Last updated: June 21, 2016
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: April 2015
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Vitamin D Deficiency

Intervention

Drug:
• CTAP101 Capsules
At week 12, eligible subjects will continue to take 2 capsules(30 mcg each capsule) CTAP101 daily
• Calcitriol
At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily
• Doxercalciferol
At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily
• Paricalcitol
At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Ireland Global Holdings Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of confirmed hypercalcemia (serum calcium >10.3 mg/dL)		up to 12 months	Yes
Secondary	Incidence of confirmed hyperphosphatemia (>5.5 mg/dL)		up to 12 months	Yes
Secondary	Mean percent reduction from baseline for plasma intact parathyroid hormone (iPTH)		up to 12 months	No
Secondary	Mean absolute change from baseline for serum total 25-hydroxyvitamin D		up to 12 months	No
Secondary	Mean absolute change from baseline for serum calcium		up to 12 months	No
Secondary	Mean absolute change from baseline for serum phosphorus		up to 12 months	No