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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00617474
Enrollment
50
Registered
2008-02-18
Start date
2008-03-31
Completion date
2009-03-31
Last updated
2008-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplantation, Kidney

Keywords

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

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.

Interventions

DRUGErythropoietin

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

DRUGPlacebo

placebo

Sponsors

Shahid Beheshti University of Medical Sciences
CollaboratorOTHER
Labbafinejhad Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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

Design outcomes

Primary

MeasureTime 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.May,2008

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026