Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
Information source: Genzyme
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Secondary Hyperparathyroidism; Renal Failure; Chronic Renal Insufficiency
Intervention: Hectorol (doxercalciferol capsules), 0.5mcg (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Genzyme Official(s) and/or principal investigator(s):
Ajay Duggal, M.D., Study Chair, Affiliation: Genzyme
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.
Clinical Details
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).
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Laboratory measurement of intact parathyroid hormone (iPTH)
Secondary outcome: Laboratory measurement of serum bone markers
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jose Cangiano, MD, San Juan 00918, Puerto Rico
Instituto Renal del Este, Caguas 00725, Puerto Rico
AKDHC Medical Research Services, Phoenix, Arizona 85012, United States
UCLA Diabetes Reseach Center, Alhambra, California, United States
Apex Research of Riverside, Riverside, California 92501, United States
George Washington University Hospital, Washington, District of Columbia 20037, United States
Nephrology Associates, Palm Beach Gardens, Florida 33410, United States
Discovery Medical Research Group, Ocala, Florida 34471, United States
Georgia Kidney Associates, Inc., Marietta, Georgia 30060, United States
Michigan Kidney Consultants, P.C., Pontiac, Michigan 48341, United States
Twin Cities Clinical Research, Brooklyn Center, Minnesota 55430, United States
Montefiore Medical Center, Bronx, New York, United States
University of Rochester Medical Center, Rochester, New York 14642, United States
Wake Forest University School of Medicine, Winston-Salem, North Carolina, United States
Wake Nephrology Associates, PA, Raleigh, North Carolina, United States
Altru Health System Research Center, Grand Forks, North Dakota 58201, United States
Temple University, Philadelphia, Pennsylvania, United States
DaVita Lewiston Dialysis Center, Lewiston, Pennsylvania 17044, United States
Virginia Commonwealth University, Richmond, Virginia, United States
Additional Information
US FDA Approved Full Prescribing Information for Hectorol® Capsules
Starting date: July 2005
Ending date: October 2007
Last updated: December 21, 2007
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