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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.
- Source :
-
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association [Nephrol Dial Transplant] 2008 Jun; Vol. 23 (6), pp. 2024-32. Date of Electronic Publication: 2008 Jan 16. - Publication Year :
- 2008
-
Abstract
- 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.<br />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.<br />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.<br />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.
- Subjects :
- Adolescent
Adrenal Cortex Hormones administration & dosage
Adult
Aged
Antibodies, Monoclonal, Humanized
Antilymphocyte Serum
Cyclosporine administration & dosage
Cytomegalovirus Infections diagnosis
Daclizumab
Delayed-Action Preparations administration & dosage
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug Therapy, Combination
Female
Follow-Up Studies
Graft Rejection
Graft Survival
Humans
Immunoglobulin G administration & dosage
Kidney Failure, Chronic diagnosis
Kidney Failure, Chronic mortality
Kidney Failure, Chronic surgery
Kidney Transplantation methods
Kidney Transplantation mortality
Male
Middle Aged
Mycophenolic Acid administration & dosage
Postoperative Complications drug therapy
Postoperative Complications virology
Reference Values
Treatment Outcome
Antibodies, Monoclonal administration & dosage
Cytomegalovirus Infections drug therapy
Ganciclovir administration & dosage
Immunosuppressive Agents administration & dosage
Kidney Transplantation adverse effects
Mycophenolic Acid analogs & derivatives
Subjects
Details
- Language :
- English
- ISSN :
- 1460-2385
- Volume :
- 23
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
- Publication Type :
- Academic Journal
- Accession number :
- 18199693
- Full Text :
- https://doi.org/10.1093/ndt/gfm873