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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferric Carboxymaltose (FCM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00317226

1VIT05005

Details and patient eligibility

About

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).

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Ferric Carboxymaltose (FCM)

Experimental group

Description:

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

Treatment:

Drug: Ferric Carboxymaltose (FCM)