Prospective, randomized trial of steroid withdrawal in kidney recipients treated with mycophenolate mofetil and cyclosporine.
Our transplant centre began a prospective, randomized trial of steroid withdrawal in low risk renal transplant recipients on triple immunosuppression consisting of mycophenolate mofetil (MMF), microemulsion cyclosporine (CSA), and prednisone. One hundred and twenty patients were randomized either to discontinue or remain on steroids (60 patients per group). Study design consisted of analyses of 1-yr outcomes after study entry. This report includes the 1-yr results plus results at last follow-up (mean follow-up 3.7 yr). There were no significant differences in rates of patient and graft survival at 1 yr or at last follow-up. Additionally, the incidences of acute and chronic rejection as well as graft function were the same at 1 yr and at last follow-up. Significant improvement was noted in total serum cholesterol and bone density at 1 yr and last follow-up. Initial improvement in patient weight at 1 yr was not sustained at last follow-up. No significant impact of steroid withdrawal on serum triglycerides, blood pressure, or post-transplant diabetes mellitus was observed. To date, we have observed no immunologic risk, and some significant benefit in regards to side effects, of steroid withdrawal between 6 and 36 months after transplantation in low risk renal transplant recipients maintained on prednisone, MMF, and microemulsion CSA.


CONCLUSIONS
Steroid withdrawal in low risk kidney transplant recipients is safe and ameliorates many of the unwanted sides effects of steroid use.
Division of Transplantation, Department of General Surgery, The Ohio State University College of Medicine, Columbus, OH, USA. pelletier-1@medctr.osu.edu
Ronald P
RP
Pelletier
Baris
B
Akin
Ronald M
RM
Ferguson
D000293:Adolescent; D000328:Adult; D000368:Aged; D003404:Creatinine / Q000097:blood; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006084:Graft Rejection / Q000097:blood; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000627:therapeutic use*; D011239:Prednisolone / Q000008:administration & dosage*; D011446:Prospective Studies; D011507:Proteinuria / Q000453:epidemiology
D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D011239:Prednisolone; D003404:Creatinine; D009173:Mycophenolic Acid