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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00123461
First received: July 21, 2005
Last updated: July 28, 2009
Last verified: December 2007

July 21, 2005
July 28, 2009
July 2005
Not Provided
Laboratory measurement of intact parathyroid hormone (iPTH) [ Time Frame: 6 months ]
Laboratory measurement of iPTH
Complete list of historical versions of study NCT00123461 on ClinicalTrials.gov Archive Site
Laboratory measurement of serum bone markers [ Time Frame: 6 months ]
Not Provided
Not Provided
Not Provided
 
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
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).

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Secondary Hyperparathyroidism
  • Renal Failure
  • Chronic Renal Insufficiency
Drug: Hectorol (doxercalciferol capsules), 0.5mcg
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00123461
BCI-CH-151
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP