Safety and efficacy of steroid withdrawal two days after kidney transplantation: analysis of results at three years.
BACKGROUND
Chronic steroid therapy in spite of myriad side effects is widely used in kidney transplantation. This prospective controlled study evaluated safety and efficacy of steroid withdrawal at 2 days in kidney recipients monitored by surveillance biopsy.


METHODS
In all, 300 kidney recipients were studied; 150 in second-day steroid withdrawal group and 150 in steroid treated group (control group). Immunosuppression was basiliximab induction and maintenance was a calcineurin inhibitor and mycophenolate mofetil or sirolimus. Biopsy-proven acute rejection (BPAR) was treated by methylpredisolone. Surveillance biopsies were completed to evaluate subclinical acute rejection (SCAR) and chronic allograft nephropathy (CAN). Primary end point was acute rejection. Three-year patient and graft survival, new onset diabetes mellitus (NODM), serum creatinine and creatinine clearance were evaluated.


RESULTS
Acute rejection was diagnosed in 14% in control group and 16% in steroid withdrawal group. Three-year patient and graft survival was 89% and 79% in control and 91% and 78% in steroid withdrawal group. Serum creatinine and creatinine clearance was 1.9+/-0.8 and 59+/-11 in control group and 1.8+/-0.9 mg/dl and 61+/-10 mls/minute in steroid withdrawal group. Incidence of SCAR and progression of CAN were comparable in the 2 groups. At 3-years NODM was diagnosed in 21% in control group and 4% in steroid withdrawal group (P<0.01).


CONCLUSIONS
Two-day steroid withdrawal in kidney transplant recipients did not affect BPAR, SCAR, CAN, graft function and patient and graft survival compared to control group up to 3 years. NODM was significantly less in steroid withdrawal group. Two-day steroid withdrawal is safe and beneficial in kidney transplant recipients.
Kumar
Mysore S Anil
MS
Division of Transplantation, Drexel University College of Medicine, Feinstein Building, Broad & Vine Streets, Philadelphia, PA 19102, USA. akumar01@drexelmed.edu
Heifets
Michael
M
Moritz
Michael J
MJ
Saeed
Muhammad I
MI
Khan
Shahid M
SM
Fyfe
Billie
B
Sustento-Riodeca
Nedjema
N
Daniel
Joshua N
JN
Kumar
Aparna
A
D000208:Acute Disease; D000305:Adrenal Cortex Hormones / Q000009:adverse effects*; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D000077552:Basiliximab; D001706:Biopsy; D019703:Calcineurin / Q000008:administration & dosage; D003920:Diabetes Mellitus / Q000209:etiology; D005260:Female; D006084:Graft Rejection; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D007668:Kidney / Q000473:pathology; D016030:Kidney Transplantation / Q000009:adverse effects / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage; D013375:Substance Withdrawal Syndrome / Q000209:etiology*
D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D000077552:Basiliximab; D019703:Calcineurin