Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
- Conditions
- Anemia
- Interventions
- Drug: Ferric Carboxymaltose (FCM)
- Registration Number
- NCT00317226
- Lead Sponsor
- American Regent, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
- Subjects who completed or discontinued Protocol 1VIT04004
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ferric Carboxymaltose (FCM) Ferric Carboxymaltose (FCM) maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
- Primary Outcome Measures
Name Time Method Incidence of Treatment-emergent Adverse Events 44 week study duration
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Luitpold Pharmaceuticals Inc.
🇺🇸Norristown, Pennsylvania, United States