Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation
Phase 4
Withdrawn
- Conditions
- Kidney TransplantationRenal TransplantationReperfusion Injury
- Interventions
- Registration Number
- NCT01149993
- Lead Sponsor
- Georgetown University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Must be able to provide written informed consent.
- All recipients of a kidney from a living donor only, either a de novo transplant, or re-transplant
- 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.
- Patients between 18-80 years of age
Exclusion Criteria
- Recipients of multi-organ transplant
- Patients with known allergies of hypersensitivities to any of the drugs used in this protocol
- Recipients of kidneys from a deceased donor
- Recipients who are co-infected with Hepatitis B, Hepatitis C or HIV
- Women who are pregnant
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pre-transplant induction Thymoglobulin (anti-thymocyte globulin) subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation. pre-transplant immunosuppression Myfortic (mycophenolic acid) 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. pre-transplant immunosuppression Thymoglobulin (anti-thymocyte globulin) 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. pre-transplant induction Myfortic (mycophenolic acid) subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation. standard of care Myfortic (mycophenolic acid) 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 standard of care Thymoglobulin (anti-thymocyte globulin) 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
- Primary Outcome Measures
Name Time Method reduction in ischemia reperfusion injury one year 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.
- Secondary Outcome Measures
Name Time Method secondary outcomes one year incidence of acute rejection, graft survival, patient survival, change in cylex values