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

Renal Insufficiency

Kidney Failure, Chronic

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

Bone Density Conservation Agents

Micronutrients

All Drugs and Chemicals

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)

Number of Participants in the Intent to Treat Population With Normal Serum 25-hydroxyvitamin D at End of Treatment (EOT)

Number of Participants in the Per Protocol Population With NormalSerum 25-hydroxyvitamin D at End of Treatment (EOT)

Overall Study

Oculocerebral Syndrome With Hypopigmentation

Comparison of different dose strengths of CTAP201 after single dose.

CTAP201 Injection

Comparison of different dose strengths of doxercalciferol after single dose.

This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.

Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)

Single-Dose, Two-Period, Open Label, Dose Determination, Randomized, Cross-Over Study of CTAP201 Injection and Doxercalciferol (Hectorol) Injection in Subjects With Stage 5 CKD and SHPT on Hemodialysis

OPKO IP Holdings II, Inc.

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Hydroxycholecalciferols

Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

Dietary supplement once daily to treat prostate cancer for 28 days

Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.

doxercalciferol

Procedure: Prostatectomy for prostate cancer

conventional surgery

George Wilding, MD

RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.

PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.

OBJECTIVES:

* Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.
* Assess the toxicity of this drug in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.

* Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
* Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.

Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002	NCT02282813	Chronic Kidney ... Hyperparathyroi... Vitamin D Defic...	CTAP101 Capsule... Calcitriol Doxercalciferol Paricalcitol	18 Years -	OPKO Health, Inc.
Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002	NCT02282813	Chronic Kidney ... Hyperparathyroi... Vitamin D Defic...	CTAP101 Capsule... Calcitriol Doxercalciferol Paricalcitol	18 Years -	OPKO Health, Inc.
Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT)	NCT00792857	Chronic Kidney ... Secondary Hyper... Chronic Renal I... Chronic Renal F...	CTAP201 Injecti... Doxercalciferol	18 Years - 80 Years	OPKO Health, Inc.
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer	NCT00022412	Prostate Cancer	doxercalciferol conventional su...	21 Years - 120 Years	University of Wisconsin, Madison

Spots Global Cancer Trial Database for doxercalciferol