Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Neoplasms

Gland and Hormone Related Diseases

Rare Diseases

Kidney Diseases

Renal Insufficiency, Chronic

Renal Insufficiency

Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Neoplastic Processes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

Micronutrients

All Drugs and Chemicals

Bone Density Conservation Agents

Vitamins

Vitamin D

Cholecalciferol

1 alpha-hydroxyergocalciferol

Trace Elements

Vitamin D3

Calciferol

Hectorol (doxercalciferol capsules), 0.5mcg

Medical Monitor

The purpose of this study is to demonstrate the safety and effectiveness of Hectorol® (doxercalciferol) capsules in treating patients with Stage 3 or Stage 4 chronic kidney disease (CKD) with secondary hyperparathyroidism who have vitamin D levels in the normal range. Previous studies with doxercalciferol were conducted in patients who had low levels of vitamin D.

Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism

A Phase 4, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Assess the Efficacy and Safety of Doxercalciferol Capsules in Vitamin D-replete Subjects With Chronic Kidney Disease (CKD) Stages 3 or 4 With Secondary Hyperparathyroidism (SHPT).

Genzyme, a Sanofi Company

Kidney Failure, Chronic

Oculocerebral Syndrome With Hypopigmentation

Parathyroid Hormone

Comparison of different dose strengths of CTAP201 after single dose.

CTAP201 Injection

Comparison of different dose strengths of doxercalciferol after single dose.

Doxercalciferol

Joel Melnick, MD

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism	NCT00123461	Secondary Hyper... Renal Failure Chronic Renal I...	Hectorol (doxer...	18 Years -	Sanofi
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.

Spots Global Cancer Trial Database for chronic renal insufficiency