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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Transplantation, Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group of patient with anemia, that treated by erythropoietin

Group Type EXPERIMENTAL

Erythropoietin

Intervention Type DRUG

sub cutaneous injection, 2000 unit in per injection, 3 times 1 week.

2

Patients group with anemia that treated by placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo

Interventions

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Erythropoietin

sub cutaneous injection, 2000 unit in per injection, 3 times 1 week.

Intervention Type DRUG

Placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes