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

NCT02282813 | Completed Phase 3 Results

• 1 other identifier: CTAP101-CL-3003
• Study Type: interventional
• Target: 298
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 6 months

Secondary Outcomes (3)

• 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 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 Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)

  up to 6 months

Study Arms (4)

CTAP101 Capsules alone

EXPERIMENTAL

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

Drug: CTAP101 Capsules

CTAP101 Capsules +calcitriol

EXPERIMENTAL

CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks

Drug: CTAP101 Capsules; Drug: Calcitriol

CTAP101 Capsules +doxercalciferol

EXPERIMENTAL

CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks

Drug: CTAP101 Capsules; Drug: Doxercalciferol

CTAP101 Capsules +paricalcitol

EXPERIMENTAL

CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks

Drug: CTAP101 Capsules; Drug: Paricalcitol

Interventions

CTAP101 Capsules DRUG

At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily

Also known as: Calcifediol

CTAP101 Capsules +calcitriol; CTAP101 Capsules +doxercalciferol; CTAP101 Capsules +paricalcitol; CTAP101 Capsules alone

Calcitriol DRUG

At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily

Also known as: calcifediol

CTAP101 Capsules +calcitriol

Doxercalciferol DRUG

At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily

Also known as: calcifediol

CTAP101 Capsules +doxercalciferol

Paricalcitol DRUG

At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily

Also known as: calcifediol

CTAP101 Capsules +paricalcitol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary; Vitamin D Deficiency; Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Kidney Diseases

Interventions

Calcifediol; Calcitriol; 1 alpha-hydroxyergocalciferol; paricalcitol

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dihydroxycholecalciferols

Results Point of Contact

• Title: Douglass Laidlaw, PhD, Vice President, Medical Affairs
• Organization: OPKO Health, Inc.

dlaidlaw@opko.com

305-575-4172

Study Officials

• Joel Melnick, MD

  OPKO Renal

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 4, 2014
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 29, 2016
• Results First Posted: August 17, 2016

Record last verified: 2016-08