A pilot study of reduced dose cyclosporine and corticosteroids to reduce new onset diabetes mellitus and acute rejection in kidney transplant recipients.
BACKGROUND
New onset diabetes mellitus (NODM) and acute rejection (AR) are important causes of morbidity and risk factors for allograft failure after kidney transplantation.


METHODS
In this multi-center, open label, single-arm pilot study, 49 adult (≥18 years of age), low immunologic risk, non-diabetic recipients of a first deceased or living donor kidney transplant received early steroid reduction to 5 mg/day combined with Thymoglobulin® (Genzyme Transplant, Cambridge, MA, USA) induction, low dose cyclosporine (2-hour post-dose (C2) target of 600 to 800 ng/ml) and mycophenolic acid (MPA) therapy.


RESULTS
Six months after transplantation, two patients (4%) developed NODM and one patient (2%) developed AR. Four patients had impaired fasting glucose tolerance based on 75-g oral glucose tolerance testing (OGTT). There was one patient death. There were no episodes of cytomegalovirus (CMV) infection or BK virus nephritis. In contrast, in a historical cohort of n = 27 patients treated with Thymoglobulin induction, and conventional doses of cyclosporine and corticosteroids, the incidence of NODM and AR was 18% and 15%.


CONCLUSIONS
The pilot study results suggest that Thymoglobulin induction combined with early steroid reduction, reduced cyclosporine exposure and MPA, may reduce the incidence of both NODM and AR in low immunological risk patients. A future controlled study enriched for patients at high risk for NODM is under consideration.


BACKGROUND
ClinicalTrials.gov: http://NCT00706680.
Toronto General Hospital, 190 Elizabeth Street, M5G 2C4, Toronto, ON, Canada. edward.cole@uhn.ca.
Edward H
EH
Cole
G V Ramesh
GV
Prasad
Carl J
CJ
Cardella
Joseph S
JS
Kim
Kathryn J
KJ
Tinckam
Daniel C
DC
Cattran
Jeffrey R
JR
Schiff
David N
DN
Landsberg
Jeffrey S
JS
Zaltzman
John S
JS
Gill