The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00617474
Recruitment Status : Unknown
Verified March 2008 by Labbafinejhad Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2008
Last Update Posted : March 28, 2008
Shahid Beheshti University of Medical Sciences
Information provided by:
Labbafinejhad Hospital

Brief Summary:
The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival.

Condition or disease Intervention/treatment Phase
Transplantation, Kidney Drug: Erythropoietin Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group
Study Start Date : March 2008
Estimated Primary Completion Date : September 2008
Estimated Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Group of patient with anemia, that treated by erythropoietin
Drug: Erythropoietin
sub cutaneous injection, 2000 unit in per injection, 3 times 1 week.
Placebo Comparator: 2
Patients group with anemia that treated by placebo
Drug: Placebo

Primary Outcome Measures :
  1. We will study the well-being of renal function by evaluation of plasma Cr,GFR,PTDA scan & biopsy proven(If it is necessary to prove the rejection)about measuring of patient - graft survival. [ Time Frame: May,2008 ]

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Hb: >8 and <10 gr/dl
  • Age: >18 and <55 years
  • Cholesterol: <300 mg/dl
  • Triglyceride: <400 mg/dl
  • First Transplantation
  • Protocol of Immunosuppression: CSA + MMF + Prednisolone
  • Systolic BP: <14
  • Diastolic BP: <9

Exclusion Criteria:

  • History of specified cardiac disease
  • Second Transplantation or more
  • Hb: <7gr/dl
  • The patient needs to infusion of blood
  • Evidence of local or systemic infection, at the time of EPO injection
  • Presence of ATN / DGF after transplantation
  • Presence of emergent hypertension
  • High risk patients ( Like; PRA>50%)
  • Past history of hypersensitivity

Responsible Party: Dr.Poorrezagholi, Shaheed Beheshti Medical University Identifier: NCT00617474     History of Changes
Other Study ID Numbers: L1386
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: March 28, 2008
Last Verified: March 2008

Keywords provided by Labbafinejhad Hospital:
kidney allograft survival
Recombinant Erythropoietin
erythropoietin (Epo)-induced protein 29, human

Additional relevant MeSH terms:
Epoetin Alfa