Overview

This trial is active, not recruiting.

Condition kidney failure, chronic
Treatment iron sucrose
Phase phase 4
Sponsor University Hospital Muenster
Start date March 2004
End date March 2005
Trial size 50 participants
Trial identifier NCT00204256, Iron-Predialysis-2003, Ven-PD-03

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Change in hemoglobin from baseline to day 43
time frame:

Secondary Outcomes

Measure
Change in ferritin and transferrin saturation from baseline to day 43; incidence and severity of adverse events
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Open Randomized Phase IV Study on Intravenous Iron in Anemic Patients With Chronic Kidney Disease
Principal investigator Roland M Schaefer, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by University Hospital Muenster.