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

Phase 4

Completed

• Conditions: Secondary Hyperparathyroidism; Renal Failure; Chronic Renal Insufficiency

• Registration Number: NCT00123461
• Lead Sponsor: Genzyme, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-25
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-04
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Laboratory measurement of intact parathyroid hormone (iPTH)	6 months

Secondary Outcome Measures

Name	Time	Method
Laboratory measurement of serum bone markers	6 months

Trial Locations

Locations (19)

UCLA Diabetes Reseach Center; 🇺🇸 Alhambra, California, United States

Apex Research of Riverside; 🇺🇸 Riverside, California, United States

Discovery Medical Research Group; 🇺🇸 Ocala, Florida, United States

Georgia Kidney Associates, Inc.; 🇺🇸 Marietta, Georgia, United States

Nephrology Associates; 🇺🇸 Palm Beach Gardens, Florida, United States

Michigan Kidney Consultants, P.C.; 🇺🇸 Pontiac, Michigan, United States

Twin Cities Clinical Research; 🇺🇸 Brooklyn Center, Minnesota, United States

Wake Nephrology Associates, PA; 🇺🇸 Raleigh, North Carolina, United States

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

Altru Health System Research Center; 🇺🇸 Grand Forks, North Dakota, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

DaVita Lewiston Dialysis Center; 🇺🇸 Lewiston, Pennsylvania, United States

Jose Cangiano, MD; 🇵🇷 San Juan, Puerto Rico

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States

AKDHC Medical Research Services; 🇺🇸 Phoenix, Arizona, United States

Instituto Renal del Este; 🇵🇷 Caguas, Puerto Rico

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States