Kidney Transplantation, Renal Transplantation, Reperfusion Injury
Conditions
Keywords
living donation, kidney transplantation, delayed graft function, ischemia reperfusion injury
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.
Interventions
DRUGMyfortic (mycophenolic acid)
720mg twice a day for 7 days prior to transplantation
DRUGThymoglobulin (anti-thymocyte globulin)
up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.
Sponsors
Novartis
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| secondary outcomes | one year | incidence of acute rejection, graft survival, patient survival, change in cylex values |
Outcome results
None listed