Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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:
Sanofi
ClinicalTrials.gov Identifier:
NCT00123461
First received: July 21, 2005
Last updated: May 4, 2015
Last verified: May 2015

July 21, 2005
May 4, 2015
July 2005
October 2007   (final data collection date for primary outcome measure)
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
October 2007   (final data collection date for primary outcome measure)

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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00123461
BCI-CH-151
Not Provided
Not Provided
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Sanofi
May 2015

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