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NCT00123461 Clinical Trial

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

Renal Failure Clinical Trial

Official title:
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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00123461
Other study ID # BCI-CH-151
Secondary ID
Status Completed
Phase Phase 4
First received July 21, 2005
Last updated May 4, 2015
Start date July 2005
Est. completion date October 2007

Study information
Verified date May 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Plasma iPTH value above 110 pg/mL for CKD Stage 3 subjects or above 150 pg/mL for CKD Stage 4

- Serum 25-hydroxyvitamin D level greater than or equal to 30 ng/mL

- CKD Stage 3 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 30-59 mL/min or CKD Stage 4 evidenced by a glomerular filtration rate (GFR) from the abbreviated MDRD equation between 15-29 mL/min

Exclusion Criteria:

- Serum cCa > 9.5 mg/dL

- Serum P > 4.6 mg/dL

- Abnormal liver functions

- Anticipated requirement for maintenance hemodialysis

- Use of active vitamin D sterol therapy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Hectorol (doxercalciferol capsules), 0.5mcg

Locations
Country Name City State
Puerto Rico Instituto Renal del Este Caguas
Puerto Rico Jose Cangiano, MD San Juan
United States UCLA Diabetes Reseach Center Alhambra California
United States Montefiore Medical Center Bronx New York
United States Twin Cities Clinical Research Brooklyn Center Minnesota
United States Altru Health System Research Center Grand Forks North Dakota
United States DaVita Lewiston Dialysis Center Lewiston Pennsylvania
United States Georgia Kidney Associates, Inc. Marietta Georgia
United States Discovery Medical Research Group Ocala Florida
United States Nephrology Associates Palm Beach Gardens Florida
United States Temple University Philadelphia Pennsylvania
United States AKDHC Medical Research Services Phoenix Arizona
United States Michigan Kidney Consultants, P.C. Pontiac Michigan
United States Wake Nephrology Associates, PA Raleigh North Carolina
United States Virginia Commonwealth University Richmond Virginia
United States Apex Research of Riverside Riverside California
United States University of Rochester Medical Center Rochester New York
United States George Washington University Hospital Washington District of Columbia
United States Wake Forest University School of Medicine Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Laboratory measurement of intact parathyroid hormone (iPTH) 6 months
Secondary Laboratory measurement of serum bone markers 6 months
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