Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Georgetown University

Status and phase: Withdrawn; Phase 4

Conditions: Kidney Transplantation; Renal Transplantation; Reperfusion Injury

Treatments: Drug: Thymoglobulin (anti-thymocyte globulin); Drug: Myfortic (mycophenolic acid)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01149993

2009-496

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

pre-transplant immunosuppression

Experimental group

Description:

subjects in this arm will receive Myfortic 720mg twice daily for 7 days prior to transplantation. Intra-operatively, the donor kidney will receive an infusion of Thymoglobulin, prior to the transplantation.

Treatment:

Drug: Thymoglobulin (anti-thymocyte globulin)

Drug: Thymoglobulin (anti-thymocyte globulin)

Drug: Myfortic (mycophenolic acid)

Drug: Myfortic (mycophenolic acid)

pre-transplant induction

Experimental group

Description:

subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation.

Treatment:

Drug: Thymoglobulin (anti-thymocyte globulin)

Drug: Thymoglobulin (anti-thymocyte globulin)

Drug: Myfortic (mycophenolic acid)

Drug: Myfortic (mycophenolic acid)

standard of care

Active Comparator group

Description:

subjects in this arm will not receive any pre-transplant immunosuppression, and the donor kidney will not receive an additional dose of Thymoglobulin prior to transplantation. This is the standard of care protocol for Georgetown University Hospital

Treatment:

Drug: Thymoglobulin (anti-thymocyte globulin)

Drug: Thymoglobulin (anti-thymocyte globulin)

Drug: Myfortic (mycophenolic acid)

Drug: Myfortic (mycophenolic acid)