Steroid avoidance in renal transplantation using basiliximab induction, cyclosporine-based immunosuppression and protocol biopsies

• Published in: Clinical transplantation 2005-02, Vol.19 (1), p.61-69
• Main Authors: Anil Kumar, Mysore S, Xiao, Sheng-Guang, Fyfe, Billie, Sierka, Debra, Heifets, Michael, Moritz, Michael J, Saeed, Muhammad I, Kumar, Aparna
• Format: Article
• Language: English
• Subjects: Adolescent; Adrenal Cortex Hormones - immunology; Adrenal Cortex Hormones - therapeutic use; Adult; African Americans; African-American; Aged; Antibodies, Monoclonal - immunology; Antibodies, Monoclonal - therapeutic use; Biological and medical sciences; Biopsy; cadaveric organs; Cardiology. Vascular system; Clinical Protocols; Cyclosporine - immunology; Cyclosporine - therapeutic use; Female; Humans; Immunosuppressive Agents - immunology; Immunosuppressive Agents - therapeutic use; Kidney - pathology; kidney transplantation; Kidney Transplantation - immunology; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; post-transplant diabetes; Prospective Studies; protocol biopsy; Recombinant Fusion Proteins - immunology; Recombinant Fusion Proteins - therapeutic use; Simulect; Treatment Outcome
• ISSN: 0902-0063; 1399-0012
• DOI: 10.1111/j.1399-0012.2004.00298.x

:  Background:  Reducing chronic steroid exposure is important to minimize steroid‐related morbidity, particularly for susceptible renal transplant recipients. Steroid‐free and steroid‐sparing protocols have shown benefits, but safety has not been established for all populations. We investigated the safety of steroid avoidance (SA) in a population including African‐Americans, using modern immunosuppression with protocol biopsy monitoring. Methods:  A randomized‐controlled SA trial (early discontinuation, days 2–7) was conducted in a population (n = 77) including African‐Americans and cadaveric kidney recipients. Patients received basiliximab, cyclosporine (CsA), and mycophenolate mofetil (MMF). In controls, steroids were tapered to 5 mg prednisone/d by day 30. Protocol biopsies were performed (1, 6, 12 and 24 months) to evaluate subclinical acute rejection (SCAR) and chronic allograft nephropathy (CAN). Results:  The SA did not result in significantly higher incidences of graft loss, AR, SCAR, CAN, or renal fibrosis. SA patients experienced similar renal function, comparable serum lipid levels, and a trend toward fewer cases of new‐onset diabetes. Clinical outcomes of African‐American and non‐African‐American patients did not significantly differ. Conclusions:  The SA is safe in the context of basiliximab induction and CsA‐based immunosuppression. This protocol could minimize steroid‐related side effects in susceptible groups, including African‐Americans, without increasing the risk of AR or graft failure.