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| Sponsored by: |
Abbott |
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00062699 |
Purpose
To evaluate the survival benefit associated with Zemplar therapy as compared to Calcijex for the treatment of secondary hyperparathyroidism in subjects with Stage V chronic kidney disease on hemodialysis as measured by time to death.
| Condition | Intervention | Phase |
|
End-Stage Kidney Disease |
Drug: Zemplar (paricalcitol injection) Drug: Calcijex |
Phase IV |
| MedlinePlus related topics: | Dialysis Kidney Failure |
| Drug Information available for: | Calcitriol 19-Nor-1alpha,25-dihydroxyvitamin D2 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase IV, Prospective, Randomized, Active-Controlled, Double-Blind, Double-Dummy, Multi-Center Study to Evaluate the Survival Benefits of Zemplar Relative to Calcijex in Subjects With Stage V Chronic Kidney Disease on Hemodialysis |
| Estimated Enrollment: | 2200 |
| Study Start Date: | April 2003 |
Eligibility
| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Stage V Chronic Kidney Disease Patients on Hemodialysis requiring treatment for secondary hyperparathyroidism with vitamin D therapy
Contacts and Locations |
Show 60 Study Locations |
| Abbott |
| Study Director: | Global Medical Information 1-800-633-9110 | Abbott |
More Information
| Study ID Numbers: | M02-516 |
| First Received: | June 11, 2003 |
| Last Updated: | July 31, 2006 |
| ClinicalTrials.gov Identifier: | NCT00062699 |
| Health Authority: | United States: Food and Drug Administration |
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