Status:
COMPLETED
Erythropoietin (EPO) and Ischemia-reperfusion After Kidney Transplantation
Lead Sponsor:
Hannover Medical School
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The hematopoetic cytokine erythropoietin (EPO) has been shown to reduce programmed cell death and tissue destruction in experimental models of acute kidney ischemia-reperfusion injury. Thus, treatment...
Detailed Description
Erythropoietin (EPO) has pleiotropic effects well beyond the maintenance of red blood cell mass. In the embryo, EPO is a major regulator of vascular formation and organ growth, and EPO receptors are f...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Male or female aged 18 to 70 years without restricted legal competence and being able to follow the trial instructions
- Cadaveric renal transplant, cold ischemia time below 24 h, and standard immunosuppressive regimen
- A haemoglobin level \> 8 and \< 14 g/dl
- Treatment with standard immunosuppression (steroids, cyclosporine A, tacrolimus, MMF or azathioprine)
- In patient with diabetes mellitus HbA1c \< 9%
Exclusion
- Previous or current myelodysplastic or -proliferative disorders
- History of cancer within the last 5 years.
- Systemic chemotherapy or radiotherapy
- Higher degree renal anemia or persistent Hb \> 14 g/dl
- Treatment with other stem cell growth factors cells like GM-CSF, VEGF
- Bleeding episodes within 3 month prior transplantation
- Sitting diastolic BP \> 110 mmHg or sitting systolic BP \> 170 mmHg
- Known intolerance of rHuEpo or analogs
- Cardiovascular event within 6 months prior transplantation
- Thromboembolic event within 6 months prior transplantation
- Relevant stenosis of extra- and intracranial, and peripheral arteries
- Systemic diseases (SLE or vasculitis)
- Acute or chronic infection and/or CRP \> 10 mg/l prior transplantation
- Hemolysis or disorders of blood formation (e.g., thalassemia)
- Further organ transplants or combined organ transplantation
- Pregnancy or inadequate contraception
- Psychiatric or emotional problems, or chronic seizures
- Unwillingness to participate satisfactorily for the entire trial period
- Participation in a clinical trial within 30 days prior to study inclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00425698
Start Date
February 1 2007
End Date
November 1 2009
Last Update
September 28 2010
Active Locations (1)
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1
Hannover Medical School
Hanover, Germany, 30625