Overview

Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Status:
Withdrawn

Trial end date:
2012-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Georgetown University

Collaborator:

Novartis

Treatments:

Antilymphocyte Serum
Mycophenolate mofetil
Mycophenolic Acid
Thymoglobulin

Criteria

Inclusion Criteria:

1. Must be able to provide written informed consent.

2. All recipients of a kidney from a living donor only, either a de novo transplant, or
re-transplant

3. All patients evaluated and listed with the United Network for Organ Sharing (UNOS) who
are eligible to receive a kidney transplant under GUH's standard protocol.

4. Patients between 18-80 years of age

Exclusion Criteria:

1. Recipients of multi-organ transplant

2. Patients with known allergies of hypersensitivities to any of the drugs used in this
protocol

3. Recipients of kidneys from a deceased donor

4. Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV

5. Women who are pregnant

6. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, including women whose career, lifestyle or sexual orientation
precludes intercourse with a male partner unless they agree to avoid pregnancy
throughout the duration of the trial and for 3 months following the trial.