Conditions: Anemia
Keywords: Anemia CKD Chronic Kidney Disease Iron Maintenance Dose
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 145
Healthy volunteers: no

Brief 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).

Detailed description:
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.

Arms:
arm 1: maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit

Interventions: intervention 1: Ferric Carboxymaltose (FCM)
Intervention descriptions: intervention 1: maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit

Protocol document: