Status:
COMPLETED
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Secondary Hyperparathyroidism
Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 secondar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00123461
Start Date
July 1 2005
End Date
October 1 2007
Last Update
May 5 2015
Active Locations (19)
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1
AKDHC Medical Research Services
Phoenix, Arizona, United States, 85012
2
UCLA Diabetes Reseach Center
Alhambra, California, United States
3
Apex Research of Riverside
Riverside, California, United States, 92501
4
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037