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

This study is not yet open for participant recruitment.

Verified by Labbafinejhad Hospital, March 2008

First Received: February 6, 2008 Last Updated: March 27, 2008 History of Changes

Sponsors and Collaborators:	Labbafinejhad Hospital Shaheed Beheshti Medical University
Information provided by:	Labbafinejhad Hospital
ClinicalTrials.gov Identifier:	NCT00617474

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 I

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group

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

No Contacts or Locations Provided

More Information

No publications provided

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

Keywords provided by Labbafinejhad Hospital:

erythropoietin
kidney allograft survival
Recombinant Erythropoietin
erythropoietin (Epo)-induced protein 29, human

Study placed in the following topic categories:

Epoetin Alfa
Hematinics

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009