A Phase 4 Study to Determine Dosing of Hectorol® Capsules When Converting From Zemplar® Injection
This study has been completed.
Sponsor:
Genzyme
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00463021
First received: April 18, 2007
Last updated: July 30, 2009
Last verified: December 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Secondary Hyperparathyroidism |
Drug: Hectorol (doxercalciferol capsules) Drug: Zemplar (paricalcitol injection) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Genzyme:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00463021
Locations
| United States, California | |
| Downey, California, United States | |
| Paramount, California, United States | |
| United States, Florida | |
| Hudson, Florida, United States | |
| United States, Georgia | |
| Augusta, Georgia, United States | |
| Decatur, Georgia, United States | |
| United States, Pennsylvania | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| Nashville, Tennessee, United States | |
| United States, Virginia | |
| Norfolk, Virginia, United States | |
Sponsors and Collaborators
Genzyme
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
No publications provided
| Responsible Party: | Medical Monitor, Genzyme Corporation |
| ClinicalTrials.gov Identifier: | NCT00463021 History of Changes |
| Other Study ID Numbers: | HECT00306 |
| Study First Received: | April 18, 2007 |
| Last Updated: | July 30, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Genzyme:
|
Hectorol (doxercalciferol capsules) Zemplar (paricalcitol injection) |
Additional relevant MeSH terms:
|
Hyperparathyroidism Hyperparathyroidism, Secondary Renal Insufficiency, Chronic Parathyroid Diseases Endocrine System Diseases Renal Insufficiency Kidney Diseases Urologic Diseases |
1 alpha-hydroxyergocalciferol Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 19, 2013