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Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

NCT01149993 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2014-06-09

No results posted yet for this study

Summary

Patients undergoing living donor renal transplant will be asked to participate to determine whether pre-operative dosing of immunosuppressive medication, and the donor organ receiving an additional dose of antibody induction therapy helps to alleviate potential damage to the transplanted organ post-transplant. A number of lab tests will be done post-transplant to determine how well the kidney is functioning.

Conditions

  • Kidney Transplantation
  • Renal Transplantation
  • Reperfusion Injury

Interventions

DRUG

Myfortic (mycophenolic acid)

720mg twice a day for 7 days prior to transplantation

DRUG

Myfortic (mycophenolic acid)

720mg twice a day after transplant

DRUG

Thymoglobulin (anti-thymocyte globulin)

up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.

DRUG

Thymoglobulin (anti-thymocyte globulin)

standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Joseph K Melancon, MD · Georgetown University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01149993 on ClinicalTrials.gov