Immunosuppression without calcineurin inhibition: optimization of renal function in expanded criteria donor renal transplantation.
BACKGROUND
To assess the efficacy of calcineurin inhibitor (CNI)-free immunosuppression vs. calcineurin-based immunosuppression in patients receiving expanded criteria donor (ECD) kidneys.


METHODS
Thirteen recipients of ECD kidneys were enrolled in this pilot study and treated with induction therapy and maintained on sirolimus, mycophenolate mofetil (MMF) and prednisone. A contemporaneous control group was randomly selected comprised of 13 recipients of ECD kidneys who had been maintained on CNI plus MMF and prednisone.


RESULTS
For the study group vs. the control group, two-yr graft survival was 92.3% vs. 84.6% (p = NS), two-yr patient survival was 100% vs. 92.3% (p = NS) and the acute rejection rates were 23% vs. 31% (p = NS), respectively. Renal function was significantly better in the study group compared with control up to the six-month mark, after which, it remained numerically but not statistically significant. Complications were more common in the study group, but serious adverse events requiring discontinuation were rare.


CONCLUSIONS
This pilot study demonstrates that CNI-free regimens can be safely implemented in patients receiving ECD kidneys with excellent two-yr patient and graft survival and good renal allograft function. Longer follow-up in larger randomized controlled trials are necessary to establish these findings.
Luke
Patrick P W
PP
Multi Organ Transplant Program, London Health Sciences Center, London, ON, Canada. patrick.luke@lhsc.on.ca
Nguan
Christopher Y
CY
Horovitz
David
D
Gregor
Laura
L
Warren
Jeff
J
House
Andrew A
AA
D065095:Calcineurin Inhibitors; D016022:Case-Control Studies; D005260:Female; D006084:Graft Rejection / Q000276:immunology / Q000517:prevention & control; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007165:Immunosuppression Therapy; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000517:prevention & control*; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D010865:Pilot Projects; D011241:Prednisone / Q000627:therapeutic use; D011446:Prospective Studies; D020123:Sirolimus / Q000627:therapeutic use; D015996:Survival Rate; D016896:Treatment Outcome; D014850:Waiting Lists
D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D011241:Prednisone; D020123:Sirolimus