Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose (FCM)
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia, CKD, Chronic Kidney Disease, Iron, Maintenance Dose
Eligibility 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
Sites / Locations
- Luitpold Pharmaceuticals Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ferric Carboxymaltose (FCM)
Arm Description
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Outcomes
Primary Outcome Measures
Incidence of Treatment-emergent Adverse Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00317226
Brief Title
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, CKD, Chronic Kidney Disease, Iron, Maintenance Dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Intervention Description
maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit
Primary Outcome Measure Information:
Title
Incidence of Treatment-emergent Adverse Events
Time Frame
44 week study duration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Luitpold Pharmaceuticals Inc.
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
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