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Intravenous Iron in Patients With Anemia of Chronic Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital Muenster.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00204256
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.


Condition Intervention Phase
Kidney Failure, Chronic
 Drug: Iron sucrose
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Randomized Phase IV Study on Intravenous Iron in Anemic Patients With Chronic Kidney Disease

Resource links provided by NLM:

Drug Information available for: Sucrose
U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • Change in hemoglobin from baseline to day 43

Secondary Outcome Measures:
  • Change in ferritin and transferrin saturation from baseline to day 43; incidence and severity of adverse events

Estimated Enrollment: 50
Study Start Date: March 2004
Estimated Study Completion Date: March 2005
Detailed Description:

This is a randomized, open label, phase IV study in anemic predialysis patients (Hb between 8 and 11.5 g/dl) who require iron supplementation. The duration of the study for each patient will be approximately 6 months. Patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (days 1-43). Treatment will be intravenous iron sucrose alone versus iron sucrose plus rhEPO. The main treatment evaluation will at the end of the correction phase: The primary end-point will be the change of hemoglobin during correction phase. Secondary end-points will be the change of ferritin and transferrin saturation from baseline to day 43. Safety assessments will include recording of adverse events, vital signs, physical examinations and clinical laboratory tests. Incidence and severity of adverse events will be compared between the two different treatment arms.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Chronic kidney disease Anemia (Hb 8 - 11.5 g/dl) Age above 18 years Signed informed consent

Exclusion Criteria:

Rapid progression of kidney disease Need for dialysis Uncontrolled hypertension

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204256

Locations
Germany
University Hospital Muenster
Muenster, Westphalia, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Roland M Schaefer, MD University Hospital Muenster
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00204256     History of Changes
Other Study ID Numbers: Ven-PD-03, Iron-Predialysis-2003
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:
chronic kidney disease
anemia
intravenous iron
recombinant human erythropoetin

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Ferric oxide, saccharated
Iron
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013