Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:12 - Any
Updated:2/22/2018
Start Date:June 2005
End Date:September 2007

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Trial Summary
Trial Overview
Inclusion Criteria

Open Label Extension Study Evaluating the Long Term Safety, Tolerability and Efficacy of an Iron Maintenance Dosing Strategy Utilizing Intravenous VIT45 in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

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 (NCT00317239).

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.

Inclusion Criteria:

- Subjects who completed or discontinued Protocol 1VIT04004

Exclusion Criteria:

- Known hypersensitivity reaction to VIT-45

- Anemia not related to CKD

- Chronic, serious infection

- Recent IV iron other than study drug in past 12 weeks

- Recent blood loss within the last 12 weeks

- Need for surgery or dialysis

- Female subjects who are pregnant or lactating
We found this trial at
1
site
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania 19403
?
mi
from
Norristown, PA
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