Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Sponsor

Georgetown University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01149993

Collaborator

Novartis (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Renal Transplantation Reperfusion Injury	Drug: Myfortic (mycophenolic acid) Drug: Myfortic (mycophenolic acid) Drug: Thymoglobulin (anti-thymocyte globulin) Drug: Thymoglobulin (anti-thymocyte globulin)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Attenuating Ischemia Reperfusion Injury After Living Donor Renal Transplantation

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: pre-transplant immunosuppression 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) 720mg twice a day for 7 days prior to transplantation Drug: Myfortic (mycophenolic acid) 720mg twice a day after transplant Drug: Thymoglobulin (anti-thymocyte globulin) up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient. Drug: Thymoglobulin (anti-thymocyte globulin) standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
Experimental: pre-transplant induction 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) 720mg twice a day after transplant Drug: Thymoglobulin (anti-thymocyte globulin) up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient. Drug: Thymoglobulin (anti-thymocyte globulin) standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
Active Comparator: standard of care 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) 720mg twice a day after transplant Drug: Thymoglobulin (anti-thymocyte globulin) standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.

Arm

Intervention/Treatment

Experimental: pre-transplant immunosuppression

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)

720mg twice a day for 7 days prior to transplantation

Drug: Myfortic (mycophenolic acid)

720mg twice a day after transplant