Korean J Nephrol.  2004 Sep;23(5):785-792.

Randomized Trial of Tacrolimus Versus Cyclosporine in Steroid Withdrawal in Living Donor Renal Transplant Recipients

• Kim B
• Huh W
• Kim MO
• Yeo HM
• Kim HJ
• Kim JA
• Kim YG
• Kim DJ
• Oh HY
• Lee KW
• Kim SJ
• Joh JW
• Kang WH
• Park JH

Abstract

BACKGROUND
The introduction of new immunosuppressants has prompted several trials of steroid withdrawal immunosuppression. However, several groups have reported a higher incidence of rejection. METHODS: We conducted a randomized two-arm, parallel group, open label, prospective study to compare steroid withdrawal (at 6 months post-transplant) regimens: tacrolimus+mycophenolate mofetil (MMF) (FK group) vs cyclosporine+MMF (CyA group). Entry criteria were: first living donor transplant recipient, no diabetes mellitus (DM), no congestive heart failure, no chronic liver disease, and no acute rejection by 6 months post-transplant. The primary endpoint was a biopsy-proven acute rejection episode or treatment failure within 1 year post- transplant. RESULTS: While eighty-seven recipients were assigned to FK (n=43) and CyA group (n=44) before transplantation, seventy-six recipients (FK 39, CyA 37) could taper off steroid at 6 months post-transplant since eleven were excluded due to acute rejection within 6 months post-transplant (FK 2, CyA 3), protocol violation (FK 2, CyA 1), drug change due to side effect (CyA 2) and follow-up loss (CyA 1). After steroid withdrawal, acute rejection episode was 0% in FK group and 13.5% in CyA group (p<0.05). Other results at 12 months post-transplant are comparable: incidence of DM 7.8 vs 0% (FK group vs CyA group), incidence of hypercholesterolemia 41.0 vs 59.5%, proportion of use antihypertensives 48.7 vs 59.6%, plasma creatinine 1.21+-0.24 vs 1.31+-0.50 mg/dL (p>0.05 in every variable). CONCLUSION: These data suggest that steroid withdrawal are successful in first living donor renal transplant recipients and tacrolimus may be more effective than cyclosporine significantly in preventing acute rejection after steroid withdrawal.

Keyword

Living donor renal transplantation; Steroid withdrawal; Tacrolimus; Cyclosporine

MeSH Terms

Antihypertensive Agents
Creatinine
Cyclosporine*
Diabetes Mellitus
Follow-Up Studies
Heart Failure
Humans
Hypercholesterolemia
Immunosuppression
Immunosuppressive Agents
Incidence
Liver Diseases
Living Donors*
Plasma
Prospective Studies
Tacrolimus*
Transplantation*
Treatment Failure
Antihypertensive Agents
Creatinine
Cyclosporine
Immunosuppressive Agents
Tacrolimus