Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Georgetown University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Kidney Transplantation Renal Transplantation Reperfusion Injury

Interventions

Myfortic (mycophenolic acid)DRUG

720mg twice a day for 7 days prior to transplantation

Myfortic (mycophenolic acid)DRUG

720mg twice a day after transplant

Thymoglobulin (anti-thymocyte globulin)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

reduction in ischemia reperfusion injury

Monitor immediate graft functioning, mitochodrial membrane potential, serum creatinine, and cylex immunomonitoring to determine if pre-transplant immunosuppression, and an additional intra-operative dose of induction agent helps to reduce ischemic reperfusion injury.

Time frame: one year

Secondary Outcomes

secondary outcomes

incidence of acute rejection, graft survival, patient survival, change in cylex values

Time frame: one year

Data from ClinicalTrials.gov

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