NCT00617474

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2008

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

6 months

First QC Date

February 6, 2008

Last Update Submit

March 27, 2008

Conditions

Transplantation, Kidney

Keywords

erythropoietinkidney allograft survivalRecombinant Erythropoietinerythropoietin (Epo)-induced protein 29, human

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Group of patient with anemia, that treated by erythropoietin

Drug: Erythropoietin

2

PLACEBO COMPARATOR

Patients group with anemia that treated by placebo

Drug: Placebo

Interventions

ErythropoietinDRUG

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

1
PlaceboDRUG

placebo

2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Erythropoietin

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 18, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2008

Study Completion

March 1, 2009

Last Updated

March 28, 2008

Record last verified: 2008-03