Steroid Avoidance Immunosuppression in Low-Risk Kidney Transplant Recipients

• Published in: Transplantation proceedings Vol. 37; no. 4; pp. 1785 - 1788
• Main Authors: Heilman, R.L., Mazur, M.J., Reddy, K.S., Moss, A., Post, D., Mulligan, D.
• Format: Journal Article Conference Proceeding
• Language: English
• Published: New York, NY Elsevier Inc 01.05.2005; Elsevier Science
• Subjects: Adrenal Cortex Hormones - adverse effects; Adult; Aged; Antilymphocyte Serum - therapeutic use; Biological and medical sciences; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Humans; Immunosuppression - methods; Immunosuppressive Agents - therapeutic use; Kidney Transplantation - immunology; Male; Medical sciences; Middle Aged; Postoperative Complications - chemically induced; Postoperative Complications - prevention & control; Surgery (general aspects). Transplantations, organ and tissue grafts. Graft diseases; Tacrolimus - therapeutic use; Tissue, organ and graft immunology; Transplantation, Homologous - immunology; Steroid; Corticosteroid; Transplantation; Homotransplantation; Low risk; Kidney; Medicine; Immunosuppression; Treatment; Urinary system; Surgery; Graft; Immunosuppressive agent
• ISSN: 0041-1345; 1873-2623
• DOI: 10.1016/j.transproceed.2005.02.106

Recent clinical trials have documented the short-term safety of steroid avoidance (SA) in kidney transplant recipients. Since July 2003, we have used a SA immunosuppression protocol for low-risk kidney transplant recipients. Eligibility criteria are age ≥18, primary transplant (living or deceased donor), and tacrolimus started by postoperative day 3. Recipients were excluded if peak/current PRA was >50%/20%, or if they had a positive flow crossmatch, or if they had the recent use of corticosteroids (<6 months). All recipients received induction with rabbit anti-thymocyte globulin, total dose 6 mg/kg, or basiliximab. Recipients received 5 daily doses of corticosteroid and mycophenolate mofetil 1 gm twice daily starting on the day of transplantation. Tacrolimus was started when the serum creatinine level decreased by 20%, or by postoperative day 3. The goal for trough tacrolimus levels was 10–15 ng/mL for the first month, 8–12 ng/mL for months 2–3, and 5–10 ng/mL after month 3. Protocol biopsies (bx) were performed at reperfusion, 1 month, 4 months, and 12 months. Ninety-four kidney transplantations were performed during the study period. Sixty-seven recipients (71%) were eligible and enrolled in SA. Characteristics of the 67 SA recipients: mean age, 53 years (range, 26–70); 41% female; 67% Caucasian; 24% Hispanic; 15% African American; and 5% Native American. Also, 77% received a living donor kidney. The mean follow-up was 180 days (range, 10–360). At last follow-up, 91% remained steroid-free. Biopsy-proven acute rejection (BPAR) occurred in 5 recipients (7.5%). Three recipients (4.5%) had clinical BPAR and 2 had subclinical. One recipient died with pneumonia 4 months following transplantation. Posttransplantation diabetes mellitus (PTDM) occurred in 2 (5%) of 38 recipients. In the initial 41 recipients, 27 had protocol bx at 1 month and 13 at 4 months available for analysis. Chronic allograft nephropathy (CAN) was present on protocol bx in 48% at 1 month and 69% at 4 month. Actuarial (Kaplan-Meier method) patient and graft survival rates at 351 days were 97.8% and 96.8%, respectively. SA with anti-thymocyte globulin induction in low-immunologic risk kidney transplant recipients is safe and is associated with a low risk of BPAR. The incidence of PTDM appears to be lower.