A RANDOMIZED MULTICENTER TRIAL OF THE ANTI-ICAM-1 MONOCLONAL ANTIBODY (ENLIMOMAB) FOR THE PREVENTION OF ACUTE REJECTION AND DELAYED ONSET OF GRAFT FUNCTION IN CADAVERIC RENAL TRANSPLANTATION
In: Transplantation, Jg. 67 (1999-03-01), S. 729-736
Online
unknown
Zugriff:
Background. T-cell activation through T-cell receptor engagement requires co-stimulatory molecules and also adhesion molecules such as ICAM-1. Moreover ICAM-1 mediates leukocyte invasion from the blood into tissue during inflammatory processes. In animal studies using mouse monoclonal antibodies against ICAM-1 (enlimomab), renal allograft survival has been improved and reperfusion damage from ischemia reduced. The European Anti-ICAM-1 Renal Transplant Study (EARTS) was a randomized, double-blind, parallel-group, placebo-controlled study lasting 1 year and performed in 10 transplant centers in Europe. Methods. A total of 262 recipients of cadaveric kidneys were given either enlimomab or a placebo for 6 days and were given triple immunosuppressive therapy of cyclosporine, azathioprine, and prednisolone. The primary efficacy endpoint was the incidence of the first acute rejection within 3 months, and each event was assessed by a committee including investigators and independent pathologists. Results. There was no significant difference in the incidences of first acute rejection at 3 months between the placebo and enlimomab groups (39% vs. 45%), and enlimomab did not reduce the risk of delayed onset of graft function (DGF) (26% vs. 31%). Neither was there a difference in patient survival (95% vs. 91%) or graft survival (89% vs. 84%) at 1 year. Fatal events occurred in 19 (7%) patients (7 placebo, 12 enlimomab). Clinically, the most important non-fatal adverse events were infections; however, there was no statistically significant difference between the incidences in the two groups (70% vs. 79%). Conclusion. Short term enlimomab induction therapy after renal transplantation did not reduce the rate of acute rejection or DGF.
Titel: |
A RANDOMIZED MULTICENTER TRIAL OF THE ANTI-ICAM-1 MONOCLONAL ANTIBODY (ENLIMOMAB) FOR THE PREVENTION OF ACUTE REJECTION AND DELAYED ONSET OF GRAFT FUNCTION IN CADAVERIC RENAL TRANSPLANTATION
|
---|---|
Autor/in / Beteiligte Person: | Päl Foyn Jørgensen ; Spieker, Claus ; Isoniemi, Helena ; Nicholls, Anthony ; Lins, Lars-eric ; Kirste, Günter ; Hendry, Bruce M. ; Ekberg, Henrik ; Neumayer, Hans-Hellmut ; Bentdal, Øystein ; Hasche, Georg ; Nh, Persson ; Bäckman, Lars ; Salmela, Kaija ; Wramner, L. ; Hauser, Ingeborg A. |
Link: | |
Zeitschrift: | Transplantation, Jg. 67 (1999-03-01), S. 729-736 |
Veröffentlichung: | Ovid Technologies (Wolters Kluwer Health), 1999 |
Medientyp: | unknown |
ISSN: | 0041-1337 (print) |
DOI: | 10.1097/00007890-199903150-00015 |
Schlagwort: |
|
Sonstiges: |
|