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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Labbafinejhad Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Shahid Beheshti Medical University
Information provided by:
Labbafinejhad Hospital
ClinicalTrials.gov Identifier:
NCT00617474
First received: February 6, 2008
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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 Intervention Phase
Transplantation, Kidney
Drug: Erythropoietin
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Labbafinejhad Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr.Poorrezagholi, Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00617474     History of Changes
Other Study ID Numbers: L1386, 200786
Study First Received: February 6, 2008
Last Updated: March 27, 2008
Health Authority: Iran: Ministry of Health

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

Additional relevant MeSH terms:
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014