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NCT00123461 · ClinicalTrials.gov registry record · Phase 4
Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism
A Phase 4 study of Renal Failure and Secondary Hyperparathyroidism, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 70
- Enrollment target
- 19
- Study locations
NCT00123461 is a Phase 4 study of Renal Failure and Secondary Hyperparathyroidism that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 70 participants, below the 295-participant average among 11 other Renal Failure trials with a reported enrollment target (76% lower). The trial reports 19 study locations across 13 states.
The verdict
NCT00123461, a Phase 4 study of Renal Failure and Secondary Hyperparathyroidism, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 70 participants
- Enrollment target
- 19
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Hectorol (doxercalciferol capsules), 0.5mcg
Study Locations (19)
California
- UCLA Diabetes Reseach Center - Alhambra
- Apex Research of Riverside - Riverside
Florida
- Discovery Medical Research Group - Ocala
- Nephrology Associates - Palm Beach Gardens
New York
- University of Rochester Medical Center - Rochester
- Montefiore Medical Center - The Bronx
North Carolina
- Wake Nephrology Associates, PA - Raleigh
- Wake Forest University School of Medicine - Winston-Salem
Pennsylvania
- DaVita Lewiston Dialysis Center - Lewiston
- Temple University - Philadelphia
Other
- Instituto Renal del Este - Caguas
- Jose Cangiano, MD - San Juan
Arizona
- AKDHC Medical Research Services - Phoenix
District of Columbia
- George Washington University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2005-07 |
| Est. Completion | 2007-10 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00123461
The ClinicalTrials.gov registry entry for NCT00123461 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 295-participant average among 11 other Renal Failure trials with a reported enrollment target (76% lower). The listed sponsor is Genzyme, a Sanofi Company, which has 196 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Renal Failure appearing as the primary indexed condition, and to 1 intervention - of which Hectorol (doxercalciferol capsules), 0.5mcg is the first listed.
NCT00123461 reports 19 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT00123461 about?
NCT00123461 is a clinical study titled "Study of Safety and Efficacy of Doxercalciferol in Patients With Chronic Kidney Disease, Stage 3 or 4, and Secondary Hyperparathyroidism". 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 doxercalc...
What is the current status of trial NCT00123461?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 70 participants. The study started on 2005-07. Estimated completion is 2007-10.
What conditions does trial NCT00123461 study?
This clinical trial studies the following conditions: Renal Failure, Secondary Hyperparathyroidism, Chronic Renal Insufficiency.
What interventions are being tested in trial NCT00123461?
The interventions under investigation include: Hectorol (doxercalciferol capsules), 0.5mcg (DRUG).
Who is sponsoring clinical trial NCT00123461?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00123461 being conducted?
This trial has 19 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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