- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00236964
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
January 22, 2018 updated by: American Regent, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis.
The duration of the study was five months.
After screening procedures including multiple hemoglobin values, patients were randomly assigned to either IV Iron Sucrose (200mg X 5) or oral iron sulfate (325mg TID)for 29 days.
Safety assessments included the recording of all adverse events, physical examinations, vital signs, electrocardiograms and clinical laboratory tests.
Efficacy parameters included hematologic parameters.
Study Type
Interventional
Enrollment
78
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Creatine Clearance <40 mL/min
- Average Baseline Hemoglobin < 10.5g/dL
- TSAT < 25% and Ferritin <300ng/mL
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Mean Change in Hemoglobin and Serum Ferritin at day 43
|
Secondary Outcome Measures
Outcome Measure |
---|
Clinical success (change in Hgb > 12 & Change in Ferritin 180)
|
Maximum change in Hemoglobin during the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mark Falone, MD, Medical Director
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Study Completion
May 1, 2002
Study Registration Dates
First Submitted
October 7, 2005
First Submitted That Met QC Criteria
October 7, 2005
First Posted (Estimate)
October 12, 2005
Study Record Updates
Last Update Posted (Actual)
January 24, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1VEN99012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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