NCT00815867

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Kidney Failure

Interventions

Type	Name	Description
DRUG	epoetin beta (NeoRecormon ®)	comparison of administration of high dosage of epoetin vs no administration of epoetin 30000 UI: 4 injections

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-04-01
• Completion: 2009-09-01
• First posted: 2008-12-31
• Last updated: 2016-04-28

Locations

17 sites across 1 country: France