NCT00425698

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 with high dose recombinant human EPO (rHuEPO) may prevent kidney tissue damage and loss of renal function after successful kidney transplantation in humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 23, 2010

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

Enrollment Period

2.2 years

First QC Date

January 22, 2007

Results QC Date

August 4, 2010

Last Update Submit

September 23, 2010

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)

    Estimated glomerular filtration rate (eGFR) was assessed using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)equation

    42 days after transplantation

Secondary Outcomes (1)

  • Kidney Graft Function by Estimated Glomerular Filtration Rate (eGFR)

    6 month after transplantation

Study Arms (2)

intravenous erythropoietin

ACTIVE COMPARATOR

Erythropoietin alpha 3 x 40.000 IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation

Drug: Recombinant erythropoietin alpha (rHuEPO alpha)Drug: Placebo

intravenous placebo

PLACEBO COMPARATOR

Placebo 3x IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation

Drug: Placebo

Interventions

Recombinant erythropoietin alpha (rHuEPO alpha)DRUG

Erythropoietin alpha 3 x 40.000 IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation

Also known as: Erypo
intravenous erythropoietin
PlaceboDRUG

Placebo 3x IU intraarterial or intravenous within 7 days after cadaveric kidney transplantation

intravenous erythropoietinintravenous placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Results Point of Contact

Title
Prof. Dr. Danilo Fliser
Organization
Saarland University Medical Centre
indfli@uks.eu
(49) 6841

Study Officials

  • Danilo Fliser, MD

    Saarland University Medical Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2007

First Posted

January 23, 2007

Study Start

February 1, 2007

Primary Completion

May 1, 2009

Study Completion

November 1, 2009

Last Updated

September 28, 2010

Results First Posted

September 23, 2010

Record last verified: 2010-09

Locations

DE(1)