NDT Advance Access published online on January 16, 2008
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfm873
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CMV infections after two doses of daclizumab versus thymoglobulin in renal transplant patients receiving mycophenolate mofetil, steroids and delayed cyclosporine A
1 CHU Poitiers, Service de Néphrologie, 350 avenue Jacques Cœur, 86021 Poitiers, France 2 CHU Tours, Service de Néphrologie, 2 Boulevard Tonnelle, 37044 Tours, France 3 CHU Rennes, Service de Néphrologie, 2 rue Henri Le Guilloux, 35033 Rennes, France 4 CHU Amiens, Service de Néphrologie, Place Victor Pauchet, 80054 Amiens, France 5 CHU Limoges, Service de Néphrologie, 2 avenue Martin Luther King, 87000 Limoges, France 6 CHU Rouen, Service de Néphrologie, 1 rue Germont, 76031 Rouen, France 7 CHU Caen, Service de Néphrologie, Avenue Clémenceau, 14033 Caen, France 8 CHU Reims, Service de Néphrologie, 645 rue Cognacq Jay, 51092 Reims, France 9 CHU Strasbourg, Service de Néphrologie, 1 place de l’Hopital, 67091 Strasbourg, France 10 CHU Poitiers, Service Anatomo-Pathologie, 350 avenue Jacques Cœur, 86021 Poitiers, France 11 ROCHE France, 52 Boulevard du Parc, 92521 Neuilly-sur-Seine, France
Correspondence and offprint requests to: Ramzi Abou-Ayache, Service de Néphrologie, CHU La Milétrie, 350 Av Jacques Cœur, 86021 Poitiers, France. Tel: +33-5-49-44-41-59; Fax: +33-5-49-44-42-36; E-mail: r.abou-ayache{at}chu-poitiers.fr
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Abstract |
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Background. Cytomegalovirus (CMV) infection is a major complication after renal transplantation and is involved in graft rejection. The anti-interleukin-2-receptor antibody daclizumab reduces the incidence of acute rejection without increasing the incidence of CMV infection.
Methods. This multicentre, randomized trial compared safety and efficacy, at 1 year, of two doses of daclizumab (54 patients, group D) with thymoglobulin (55 patients, group T) plus delayed cyclosporine (CsA), MMF (mycophenolate mofetil) and steroids in first cadaver kidney transplant patients. Primary criterion was CMV infection/syndrome/disease. D+/R– patients received oral ganciclovir prophylaxis for 90 days.
Results. Status for CMV was identical in the both groups. The incidence of CMV infection/syndrome/disease was 39% in group D versus 51% in group T (NS). Time to onset of CMV replication was delayed in group D (P = 0.015) and mean number of pp65-positive cells was lower at 4 and 6 months (P < 0.001). Incidence of symptomatic CMV episodes was not reduced in whole group D (5.6% versus 16.4%, NS), but lower in D+/R+ and D–/R+ patients without chemoprophylaxis, compared to group T (2.8% versus 21.6%, P = 0.028). Patient and graft survivals and incidence of biopsy-proven acute rejection were identical.
Conclusions. Limited dosing regimen of daclizumab with MMF, steroids and delayed CsA introduction was safe and effective. The incidence of CMV infection was not significantly different, but without chemoprophylaxis, clinical manifestations and viral replication were reduced with this regimen.
Keywords: cytomegalovirus; daclizumab; kidney transplantation; thymoglobulin
Received for publication: 20. 9.07
Accepted in revised form: 16.11.07