Phase 3 N=88 Randomized Double-blind Prevention

Erythropoietin (EPO) and Ischemia-reperfusion After Kidney Transplantation

Kidney Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT00425698 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

Sep 2010

Primary outcome: Primary: Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR) — 47; 46 ml/min — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Recombinant erythropoietin alpha (rHuEPO alpha) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hannover Medical School
Primary completion: May 2009

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)	—	—

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.

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

View full record on ClinicalTrials.gov →

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.