Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant — Neo-PDGF  

Kidney Failure Clinical Trial

Official title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

Status Completed

Clinical Trial Summary

Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.

Clinical Trial Description

French study, prospective, multicenter, open, randomized into two parallel groups:

Group A: NeoRecormon ® 30000 UI: 4 injections Group B: control group without administration of the medical product

Period of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months.

Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant.

Secondary objectives:

Comparing the 2 groups at all times J0 to J90:

• The evolution of renal function

• The survival of patients and grafts

• The time of onset and incidence of acute rejection proved by biopsy

• The correction of anemia

• The need for transfusions

• The need for EPO

• Quality of Life

• The safety processing ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

• NCT number: NCT00815867
• Study type: Interventional
• Source: Centre Hospitalier Universitaire, Amiens
• Status: Completed
• Phase: Phase 3
• Start date: October 2007
• Completion date: September 2009