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

Transplantation, Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00617474
• Other study ID #: L1386
• Secondary ID: 200786
• Status: Not yet recruiting
• Phase: Phase 1
• First received: February 6, 2008
• Last updated: March 27, 2008
• Start date: March 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2008
• Source: Labbafinejhad Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transplantation, Kidney

Intervention

Drug:
• Erythropoietin
sub cutaneous injection, 2000 unit in per injection, 3 times 1 week.
• Placebo
placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Labbafinejhad Hospital	hahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes