Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Neoplasms

Gland and Hormone Related Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Kidney Diseases

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Renal Insufficiency

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Vitamin D Deficiency

Parathyroid Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Neoplastic Processes

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Endocrine System Diseases

Chronic Graft Versus Host Disease

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Vasoconstrictor Agents

Vitamins

Vitamin D

Cholecalciferol

Calcitriol

Calcifediol

Parathyroid Hormone

1 alpha-hydroxyergocalciferol

Hormones

Calcium

Calcium, Dietary

Trace Elements

Vitamin D3

Calciferol

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

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

CTAP101 Capsules

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

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

Doxercalciferol

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

Paricalcitol

Joel Melnick, MD

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.

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.

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

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)

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

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 serum 25-hydroxyvitamin D \>/= 30 ng/mL 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)

OPKO Health, Inc.

CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.

CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.

CTAP101 Capsules (Not Randomized; 6 Mos Treatment)

CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.

CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily

CTAP101 Capsules (Not Randomized; 12 Mos Treatment)

CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.

CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive

CTAP101 Capsules (Monotherapy; 12 Mos Treatment)

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Intent to treat population: includes subjects receiving CTAP101 capsules only in the extension trial (up to 6 months total active therapy, subjects receiving up to 12 months receiving CTAP101 capsules (6 months in the previous trials and up to 6 months in the extension) with or without being randomized to CTAP101 capsules plus adjunctive therapy.

Douglass Laidlaw, PhD, Vice President, Medical Affairs

CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.

CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily.

CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.

CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily

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 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)

Spots Global Cancer Trial Database for Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial