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

• Sponsor: Labbafinejhad Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00617474
• Collaborator: Shahid Beheshti University of Medical Sciences (Other)
• Enrollment: 50
• Arms: 2
• Duration (Months): 12

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2008
• Anticipated Primary Completion Date: Sep 1, 2008
• Anticipated Study Completion Date: Mar 1, 2009

Arms and Interventions

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; placebo

Outcome Measures

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. [May,2008]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Labbafinejhad Hospital
• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00617474
• Other Study ID Numbers: L1386; 200786
• First Posted: Feb 18, 2008
• Last Update Posted: Mar 28, 2008
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: erythropoietin; kidney allograft survival; Recombinant Erythropoietin; erythropoietin (Epo)-induced protein 29, human
• Additional relevant MeSH terms: Epoetin Alfa

Study Results

No Results Posted as of Mar 28, 2008