Steroid-avoidance immunosuppression regimen in live-donor renal allotransplant recipients: a prospective, randomized, controlled study.
OBJECTIVE
Steroids have occupied a major role in renal transplantation for more than 4 decades. However, chronic use of steroids is associated with numerous comorbidities. We sought to elucidate the safety and efficacy of a steroid-free immunosuppression regimen in live-donor renal transplant recipients.


METHODS
One hundred patients were randomized to receive tacrolimus, mycophenolate mofetil, basiliximab induction, and steroids only for 3 days (experimental group, n=50 patients) or tacrolimus, mycophenolate mofetil, basiliximab induction, and steroid maintenance (control group, n=50 patients,). The median follow-up was 12 months.


RESULTS
Patient and graft survival rates were 100% in both groups. The rate of biopsy-proven acute rejection was 16% in both groups. For patients in the control group, the mean serum creatinine level was 111.22 micromol /L compared with 110.39 micromol/L in patients in the experimental group. Posttransplant hypertension was encountered in 4% of the patients in the experimental group compared with 24% of the patients in the control group (P = .0009). Posttransplant diabetes mellitus was detected in 4% of the patients in the experimental group compared with 16% of the patients in the control group (P = .037). Posttransplant weight gain was reported in 6% of the patients in the experimental group compared with 15% of the patients in the control group (P = .001). The chronic allograft damage indexes of biopsy specimens at 1-year follow-up were comparable in both groups (2.48 vs 2.28, respectively) (P = .16).


CONCLUSIONS
In living-donor renal transplant recipients with low immunologic risk, steroid avoidance (using basiliximab induction, tacrolimus, mycophenolate mofetil maintenance, and 3 days' steroid treatment) is feasible, safe, and carries with it fewer morbidities compared with the same immunosuppressive protocol with steroid maintenance. Longer follow-ups are required to prove the safety of this regimen.
Nematalla
Ahmed H
AH
Urology and Nephrology Center, Mansoura, Egypt. ahmednematalla@yahoo.com
Bakr
Mohmed A
MA
Gheith
Osama A
OA
Elagroudy
Amgad E
AE
Elshahawy
El-Metwally
el-M
Aghoneim
Mohamed
M
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D000077552:Basiliximab; D002648:Child; D002675:Child, Preschool; D005260:Female; D006084:Graft Rejection / Q000276:immunology; D006085:Graft Survival / Q000187:drug effects; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007239:Infections / Q000209:etiology / Q000276:immunology; D016030:Kidney Transplantation / Q000276:immunology / Q000379:methods*; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000009:adverse effects; D013256:Steroids / Q000008:administration & dosage* / Q000009:adverse effects; D016559:Tacrolimus / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D013256:Steroids; D000077552:Basiliximab; D009173:Mycophenolic Acid; D016559:Tacrolimus