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

March 27, 2008 updated by: Labbafinejhad Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
May,2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Labbafinejhad Hospital

Collaborators

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

September 1, 2008

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 15, 2008

First Posted (Estimate)

February 18, 2008

Study Record Updates

Last Update Posted (Estimate)

March 28, 2008

Last Update Submitted That Met QC Criteria

March 27, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L1386
  • 200786

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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