Back to resultsVIT45 Versus Oral Iron in the 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
Ferrous Sulfate tablets
Ferric Carboxymaltose (FCM)
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring Anemia, Chronic Kidney Disease, Iron
Eligibility Criteria
Inclusion Criteria: Males or females > or = 12 years of age NDD-CKD subjects Baseline hemoglobin < or = 11g/dl Stable erythropoietin (EPO) status Exclusion Criteria: Known hypersensitivity to ferrous sulfate or IV iron Unstable EPO status Anemia not related to CKD Chronic, serious infection Recent IV iron Recent blood transfusion Recent blood loss Need for surgery Received investigational drug within 30 days Female subjects who are pregnant or lactating
Sites / Locations
- Luitpold Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferric Carboxymaltose (FCM)
Ferrous Sulfate tablets
Arm Description
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
325 mg/TID x 8 weeks
Outcomes
Primary Outcome Measures
Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00317239
Brief Title
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Official Title
Comparison of Safety & Efficacy of a Unique Intravenous Iron (VIT45) Preparation vs Oral Iron 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
May 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
August 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
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
Detailed Description
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia
Keywords
Anemia, Chronic Kidney Disease, Iron
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
255 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
Arm Title
Ferrous Sulfate tablets
Arm Type
Active Comparator
Arm Description
325 mg/TID x 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate tablets
Intervention Description
325 mg/TID x 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Intervention Description
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
Primary Outcome Measure Information:
Title
Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL
Time Frame
anytime during the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females > or = 12 years of age
NDD-CKD subjects
Baseline hemoglobin < or = 11g/dl
Stable erythropoietin (EPO) status
Exclusion Criteria:
Known hypersensitivity to ferrous sulfate or IV iron
Unstable EPO status
Anemia not related to CKD
Chronic, serious infection
Recent IV iron
Recent blood transfusion
Recent blood loss
Need for surgery
Received investigational drug within 30 days
Female subjects who are pregnant or lactating
Facility Information:
Facility Name
Luitpold Pharmaceuticals
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20929915
Citation
Qunibi WY, Martinez C, Smith M, Benjamin J, Mangione A, Roger SD. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. Nephrol Dial Transplant. 2011 May;26(5):1599-607. doi: 10.1093/ndt/gfq613. Epub 2010 Oct 7.
Results Reference
result
Citation
Qunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.
Results Reference
result
Learn more about this trial
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
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