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

Completed · Phase 4

Conditions studied: Secondary Hyperparathyroidism, Renal Failure, Chronic Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT00123461

Run by

Genzyme, a Sanofi Company

People needed

70

Starts

2005-07-01

Expected to finish

2007-10-01

Last updated by the study team

2015-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AKDHC Medical Research Services — Phoenix, Arizona, United States
• UCLA Diabetes Reseach Center — Alhambra, California, United States
• Apex Research of Riverside — Riverside, California, United States
• George Washington University Hospital — Washington D.C., District of Columbia, United States
• Discovery Medical Research Group — Ocala, Florida, United States
• Nephrology Associates — Palm Beach Gardens, Florida, United States
• Georgia Kidney Associates, Inc. — Marietta, Georgia, United States
• Michigan Kidney Consultants, P.C. — Pontiac, Michigan, United States
• Twin Cities Clinical Research — Brooklyn Center, Minnesota, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, 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
• DaVita Lewiston Dialysis Center — Lewiston, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Instituto Renal del Este — Caguas, Puerto Rico
• Jose Cangiano, MD — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.