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

NCT ID: NCT00617474

Last Updated: 2008-03-28

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.

Detailed Description

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Conditions

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Transplantation, Kidney

Keywords

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

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

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Labbafinejhad Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shaheed Beheshti Medical University

Other Identifiers

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200786

Identifier Type: -

Identifier Source: secondary_id

L1386

Identifier Type: -

Identifier Source: org_study_id