A Randomized Prospective Study Comparing Anti-T-Lymphocyte Igs to Basiliximab in Highly Sensitized Kidney Transplant Patients.

Autor: Kamar N; Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France., Lepage B; Department of Epidemiology, USMR, Toulouse, France., Couzi L; Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, CNRS-UMR 5164 Immuno ConcEpT Université de Bordeaux, Bordeaux, France., Albano L; Department of Nephrology and Transplantation, CHU Nice, France., Durrbach A; Department of Nephrology and Kidney Transplantation, Henri Mondor Hospital, Assistance Publique-Hôpitaux de Paris, University Paris Sud, France., Pernin V; Department of Nephrology and Transplantation, CHU Montpellier, Montpellier, France., Esposito L; Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France., Hebral AL; Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France., Darres A; Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France., Lequintrec M; Department of Nephrology and Transplantation, CHU Montpellier, Montpellier, France., Cassuto E; Department of Nephrology and Transplantation, CHU Nice, France., Merville P; Department of Nephrology, Transplantation, Dialysis and Apheresis, CHU Bordeaux, CNRS-UMR 5164 Immuno ConcEpT Université de Bordeaux, Bordeaux, France., Congy N; Department of Immunology, CHU Rangueil, University Paul Sabatier, Toulouse, France., Del Bello A; Department of Nephrology, Dialysis and Organ Transplantation, CHU Rangueil, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France.
Jazyk: angličtina
Zdroj: Kidney international reports [Kidney Int Rep] 2020 Jun 02; Vol. 5 (8), pp. 1207-1217. Date of Electronic Publication: 2020 Jun 02 (Print Publication: 2020).
DOI: 10.1016/j.ekir.2020.05.020
Abstrakt: Background: Two prospective studies that were performed before the era of highly sensitive solid-phase assays have shown a lower incidence of acute rejection in highly sensitized kidney-transplant patients given polyclonal antibodies compared with those given anti-CD25 monoclonal antibodies.
Methods: This prospective pilot randomized French multicenter study aimed to compare anti-T-lymphocyte Ig (ATLG) ( n  = 32) and basiliximab ( n  = 27) in highly sensitized kidney-transplant patients without preformed donor-specific antibodies (pDSAs) as assessed by a Luminex Single-Antigen flow bead assay. Only patients with a calculated panel reactive antibody ≥50%, with at least 1 antibody with a mean fluorescence intensity ≥5000 and without a historical pDSA and without a pDSA on the day of transplantation were included.
Results: Treatment failure as defined by biopsy-proven acute rejection, patient lost to follow-up, graft loss, and death was observed in 18.8% (95% confidence interval [CI], 8.9%-37.1%) and 18.8% (95% CI, 8.9%-37.1%) in patients who received ATLG and 14.8% (95% CI, 5.8%-34.8%) and 28.2% (95% CI, 14.2%-51.2%) of patients who received basiliximab, respectively at 6 ( P  = 0.66) and 12 ( P  = 0.62) months post-transplantation. One T cell-mediated rejection was observed in ATLG-treated patients (3.1%). One antibody-mediated rejection due to a de novo donor-specific antibody (DSA) occurred in basiliximab-treated patients (3.7%). Patient survival, graft survival, kidney parameters, and infection rate were similar in the 2 groups.
Conclusion: This pilot study indicates that in highly sensitized kidney-transplant patients without pDSAs, both ATLG and basiliximab can be used efficiently and safely. However, because of the lack of power, these results should be interpreted with caution.
(© 2020 International Society of Nephrology. Published by Elsevier Inc.)
Databáze: MEDLINE
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