Intravenous Iron in Patients With Anemia of Chronic Kidney Disease

Kidney Failure, Chronic Clinical Trial

Official title:

Open Randomized Phase IV Study on Intravenous Iron in Anemic Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00204256
• Other study ID #: Ven-PD-03
• Secondary ID: Iron-Predialysis
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: March 2004
• Est. completion date: March 2005

Study information

• Verified date: September 2005
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Iron sucrose

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Muenster	Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hemoglobin from baseline to day 43
Secondary	Change in ferritin and transferrin saturation from baseline to day 43; incidence and severity of adverse events