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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Regent, Inc.; Luitpold Pharmaceuticals
• Treatments: Ferric Compounds

Criteria

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