Immunoprophylaxis with basiliximab compared with antithymocyte globulin in renal transplant patients receiving MMF-containing triple therapy.
Acute graft rejection remains a major problem in renal transplant recipients, and there is no consensus on the optimal immunosuppressive strategy. Immunoprophylaxis with Thymoglobulin or basiliximab has significantly reduced the incidence of acute rejection episodes and graft loss following kidney transplantation. This open, randomized, multicenter study investigated the efficacy and tolerability of basiliximab (20mg day 0-day 4) plus early cyclosporine from day 0 (n = 50) compared with Thymoglobulin plus delayed cyclosporine (n = 50) in adult kidney transplant patients. In addition, all patients received steroids and mycophenolate mofetil (MMF) at standard doses from day 0. Patient and graft survival rates at 12 months were 98 and 94% in the basiliximab group, respectively, compared with 100 and 96% in the Thymoglobulin' group. The incidences of biopsy-confirmed acute rejection (8.0% in each group) and treatment failure (14% in the basiliximab group vs. 8% in the Thymoglobulin group) were comparable in the two groups. There was a non-significant tendency to more dialysis (14 vs. 6%), and fewer cytomegalovirus (CMV) infections (p = 0.005) in the basiliximab group, but the percentage of clinical CMV was not different between the two groups (6 vs. 12%). Both strategies give excellent results, despite the differences in patterns, in nonhyperimmunized patients receiving their first cadaveric renal allograft.
Lebranchu
Yvon
Y
Service Nephrologie Immunologie Clinique Hĵpital Bretonneau/Tours, France. lebranchu@med.univ-tours.fr
Bridoux
Frank
F
Büchler
Matthias
M
Le Meur
Yannick
Y
Etienne
Isabelle
I
Toupance
Olivier
O
Hurault de Ligny
Bruno
B
Touchard
Guy
G
Moulin
Bruno
B
Le Pogamp
Patrick
P
Reigneau
Olivier
O
Guignard
Michel
M
Rifle
Gérard
G
D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000961:Antilymphocyte Serum / Q000009:adverse effects / Q000627:therapeutic use*; D000077552:Basiliximab; D003404:Creatinine / Q000097:blood / Q000378:metabolism; D016572:Cyclosporine / Q000493:pharmacokinetics / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D005602:France; D006084:Graft Rejection / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007676:Kidney Failure, Chronic / Q000209:etiology / Q000601:surgery; D016030:Kidney Transplantation / Q000276:immunology* / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use*; D044469:Racial Groups; D011993:Recombinant Fusion Proteins; D012449:Safety; D013997:Time Factors; D014019:Tissue Donors / Q000706:statistics & numerical data
D000911:Antibodies, Monoclonal; D000961:Antilymphocyte Serum; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D003404:Creatinine; D009173:Mycophenolic Acid