Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
1 other identifier
interventional
96
0 countries
N/A
Brief Summary
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2001
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2002
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedMay 9, 2025
January 1, 2018
1.3 years
October 7, 2005
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean Change in Hemoglobin
Change in hemoglobin g/dL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Baseline and Day 43
Mean Change in Serum Ferritin
Change in Ferritin ng/mL from baseline to Day 43 was analyzed using parametric analysis of covariance (ANCOVA).
Baseline and Day 43
Secondary Outcomes (2)
Clinical Success (Change in Hemoglobin)
Baseline and Day 43
Clinical success (change in Ferritin)
Baseline and Day 43
Study Arms (2)
Iron Sucrose
EXPERIMENTALIron sucrose 200 mg intravenous on Days 1, 8, 15, 22, and 29
Oral Iron
ACTIVE COMPARATOROral ferrous sulfate 325 mg three times a day on Days 1 to 29.
Interventions
The total dose of iron sucrose was 1,000 mg. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.
Oral iron 325 mg three time daily for 29 days. Participants also received erythropoietin 2,000 units subcutaneously on Days 1, 8, 15, 22, 29, and 36.
Eligibility Criteria
You may qualify if:
- Creatine Clearance \<40 mL/min
- Average Baseline Hemoglobin \< 10.5g/dL
- Serum Transferrin Saturation (TSAT) \< 25% and Ferritin \<300ng/mL
You may not qualify if:
- Blood Transfusion within 30days
- Uncontrolled Hypertension
- Suffering form concommitant disease of the liver
- Serious bacterial infection
- Pregnancy / lactation
- Symptomatic HIV
- Expected to under dialysis or renal transplant during study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Charytan C, Qunibi W, Bailie GR; Venofer Clinical Studies Group. Comparison of intravenous iron sucrose to oral iron in the treatment of anemic patients with chronic kidney disease not on dialysis. Nephron Clin Pract. 2005;100(3):c55-62. doi: 10.1159/000085049. Epub 2005 Apr 11.
PMID: 15824508RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Falone, MD
Medical Director
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
February 23, 2001
Primary Completion
May 30, 2002
Study Completion
May 30, 2002
Last Updated
May 9, 2025
Record last verified: 2018-01