EFFECT OF ERYTHROPOIETIN ON RENAL FUNCTION AFTER KIDNEY TRANSPLANTATION - EPO AND ISCHEMIA-REPERFUSION AFTER KIDNEY TRANSPLANTATIO
- Conditions
- 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.
- Registration Number
- EUCTR2006-002938-38-DE
- Lead Sponsor
- Hannover Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•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 <16 g/dl prior to kidney transplantation
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method