Phase 3
Completed N=88
Erythropoietin (EPO) and Ischemia-reperfusion After Kidney Transplantation
Source: ClinicalTrials.gov NCT00425698 ↗Enrolled (actual)
88
Serious AEs
4.6%
Results posted
Sep 2010
Primary outcomePrimary: Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR) — 47; 46 ml/min — p=<0.05
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 with high dose recombinant human EPO (rHuEPO) may prevent kidney tissue damage and loss of renal function after successful kidney transplantation in humans.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR) |
— | — |
| SECONDARY Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT00425698). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.