Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Conditions
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Kidney Transplantation, Renal Transplantation, Reperfusion Injury

Intervention / Treatment
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* Drug: Myfortic (mycophenolic acid)
* Drug: Myfortic (mycophenolic acid)
* Drug: Thymoglobulin (anti-thymocyte globulin)
* Drug: Thymoglobulin (anti-thymocyte globulin)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre-transplant immunosuppression<br>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. | Drug: Myfortic (mycophenolic acid)<br>* 720mg twice a day for 7 days prior to transplantation<br>Drug: Myfortic (mycophenolic acid)<br>* 720mg twice a day after transplant<br>Drug: Thymoglobulin (anti-thymocyte globulin)<br>* up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.<br>Drug: Thymoglobulin (anti-thymocyte globulin)<br>* standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.<br>|
| Experimental: pre-transplant induction<br>subjects in this arm will not receive any pre-transplant immunosuppression. However, the donor kidney will receive an infusion of Thymoglobulin prior to transplantation. | Drug: Myfortic (mycophenolic acid)<br>* 720mg twice a day after transplant<br>Drug: Thymoglobulin (anti-thymocyte globulin)<br>* up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.<br>Drug: Thymoglobulin (anti-thymocyte globulin)<br>* standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.<br>|
| Active Comparator: standard of care<br>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 | Drug: Myfortic (mycophenolic acid)<br>* 720mg twice a day after transplant<br>Drug: Thymoglobulin (anti-thymocyte globulin)<br>* standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary outcomes | incidence of acute rejection, graft survival, patient survival, change in cylex values | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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living donation, kidney transplantation, delayed graft function, ischemia reperfusion injury