A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
A Phase 4, Multi Center, Open-Label, Randomized Study to Determine Clinically Appropriate Doses of Hectorol® (Doxercalciferol Capsules) When Converting From Zemplar® (Paricalcitol Injection) for the Treatment of Secondary Hyperparathyroidism in Stage 5 Chronic Kidney Disease (CKD) Subjects on Hemodialysis.
1 other identifier
interventional
36
1 country
8
Brief Summary
Protocol HECT00306 aims to determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting from Zemplar (paricalcitol injection) for the treatment of secondary hyperparathyroidism in Stage 5 chronic kidney disease on hemodialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2007
Shorter than P25 for phase_4
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 18, 2007
CompletedFirst Posted
Study publicly available on registry
April 19, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedMay 5, 2015
May 1, 2015
April 18, 2007
May 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Conversion
10 weeks
Interventions
Eligibility Criteria
You may qualify if:
- The subject must be receiving hemodialysis three times per week for a minimum of six months.
- The subject must have been receiving Zemplar Injection for a minimum of 3 months. The subject must have been on a stable dose regimen, three times per week administration for a minimum of four weeks.
- The central laboratory assessment must be within the following ranges: serum iPTH between 150-600 pg/mL, inclusive; corrected calcium \< 10.0 mg/dL; phosphorus \< 7.0 mg/dL.
You may not qualify if:
- In the opinion of the Investigator, the subject currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any other clinically significant, unstable medical condition.
- Abnormal liver function as measured by ALT/AST greater than two times the upper limit of normal (ULN).
- The subject currently has malabsorption, severe chronic diarrhea, or ileostomy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Downey, California, United States
Unknown Facility
Paramount, California, United States
Unknown Facility
Hudson, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Norfolk, Virginia, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 18, 2007
First Posted
April 19, 2007
Study Start
April 1, 2007
Study Completion
December 1, 2007
Last Updated
May 5, 2015
Record last verified: 2015-05