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Sponsored by: |
Luitpold Pharmaceuticals |
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Information provided by: | Luitpold Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00317226 |
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004.
Condition | Intervention | Phase |
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Anemia |
Drug: VIT45 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Open Label Extension Study Evaluating the Long Term Safety, Tolerability and Efficacy of an Iron Maintenance Dosing Strategy Utilizing VIT45 in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease |
Enrollment: | 145 |
Study Start Date: | June 2005 |
Study Completion Date: | October 2006 |
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004.
In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Pennsylvania | |
Luitpold Pharmaceuticals Inc. | |
Norristown, Pennsylvania, United States, 19518 |
Study Director: | Antoinette Mangione, MD | Luitpold Pharmaceuticals |
Study ID Numbers: | 1VIT05005 |
Study First Received: | April 20, 2006 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00317226 |
Health Authority: | United States: Food and Drug Administration |
Anemia CKD Chronic Kidney Disease Iron Maintenance Dose |
Renal Insufficiency Urologic Diseases Hematologic Diseases Renal Insufficiency, Chronic Anemia |
Kidney Failure, Chronic Kidney Diseases Iron Kidney Failure |