We will investigate the effect of recombinant human erythropoietin (rHuEPO) on ischemia-reperfusion injury in patients with terminal renal failure undergoing cadaveric kidney transplantation. In this clinical setting rHuEPO is expected to have anti-apoptotic tissue protective effects.
Conditions
Interventions
Trade Name: ERYPO 40.000 I.E./ml Injektionslösung
Pharmaceutical Form: Solution for injection
INN or Proposed INN: epoetin alfa
CAS Number: 113427-24-0
Current Sponsor code: MHH - EPONTX - 01/06
Conce
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • written informed consent • male or female gender • age between 18 and 70 years • cadaveric kidney transplantion • cold ischemia time below 24 hours prior to transplantation of the kidney • treatment with standard immunosupressive agents after transplantation • HbA1C below 9% in patients with diabetes mellitus • hemoglobin >8 g/dl und =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • myelodyplastic syndrome or proliferative disease • cancer within 5 years prior to kidney transplantation • advanced renal anemia prior to kidney transplantation • polyglobulia with persistent hemoglobin >16 g/dl • treatment with other growth factors (e.g. GM-CSF) • bleeding episodes within 3 month prior to kidney transplantation • uncontrolled arterial hypertension • known hypersensitivity against rHuEPO • cardiovascular event within 6 month prior to kidney transplantation • thromembolic event within 6 month prior to kidney transplantation • chronic infection and/or persistent high sensitivity CRP >10 mg/l • chronic haemolytic disorders (e.g. thalassemia) • other organ transplants (e.g. combined pancreas/kidney transplantation) • women of childbearing potential without appropriate contraception • psychiatric disease or epilepsia • participation in another clinical trial within 30 days prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of recombinant human erythropoietin (rHuEPO) on ischemia-reperfusion injury after kidney transplantation, i.e. to investigate the effect of rHuEPO on the course of renal function after successful kidney transplantation (e.g. serum-creatinine/serum cystatin C concentration 42 days after kidney transplantation).;Secondary Objective: To assess safety and tolerabilty of high dose rHuEPO in patients with terminal renal failure undergoing cadaveric kidney transplantation. ;Primary end point(s): The primary study end point is the serum-creatinine/serum cystatin C concentration 42 days after successful cadaveric kidney transplantation. In addition, the duration of renal replacement therapy (if any) will be assessed. | — |
Countries
Germany
Outcome results
None listed