Cargando…

A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study

BACKGROUND: Induction treatment with rabbit polyclonal antithymocyte globulins (ATGs) is frequent used in kidney transplant recipients with donorspecific HLA antibodies and shows acceptable outcomes. The two commonly used ATGs, Thymoglobulin and ATG-F have slightly different antigen profile and anti...

Descripción completa

Detalles Bibliográficos
Autores principales: Burkhalter, F., Schaub, S., Bucher, Ch., Gürke, L., Bachmann, A., Hopfer, H., Dickenmann, M., Steiger, J., Binet, I.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5113896/
https://www.ncbi.nlm.nih.gov/pubmed/27855166
http://dx.doi.org/10.1371/journal.pone.0165233
_version_ 1782468257003864064
author Burkhalter, F.
Schaub, S.
Bucher, Ch.
Gürke, L.
Bachmann, A.
Hopfer, H.
Dickenmann, M.
Steiger, J.
Binet, I.
author_facet Burkhalter, F.
Schaub, S.
Bucher, Ch.
Gürke, L.
Bachmann, A.
Hopfer, H.
Dickenmann, M.
Steiger, J.
Binet, I.
author_sort Burkhalter, F.
collection PubMed
description BACKGROUND: Induction treatment with rabbit polyclonal antithymocyte globulins (ATGs) is frequent used in kidney transplant recipients with donorspecific HLA antibodies and shows acceptable outcomes. The two commonly used ATGs, Thymoglobulin and ATG-F have slightly different antigen profile and antibody concentrations. The two compounds have never been directly compared in a prospective trial in immunological high-risk recipients. Therefore we performed a prospective randomized controlled study comparing the two compounds in immunological high-risk kidney recipients in terms of safety and efficacy. METHODS: Immunological high-risk kidney recipients, defined as the presence of HLA DSA but negative CDC-B and T-cell crossmatches were randomized 1:1 to receive ATG-F or Thymoglobulin. Maintenance immunosuppressive therapy consisted of tacrolimus, mycophenolate mofetil and steroids. RESULTS: The per-protocol analysis included 35 patients. There was no immediate infusion reaction observed with both compounds. No PTLD or malignancy occurred during the follow-up in both groups. The incidence of viral and bacterial infections was similar in both groups (p = 0.62). The cumulative incidence of clinical and subclinical antibody mediated allograft rejection as well as T-cell mediated allograft rejection during the first year between ATG-F and Thymoglobulin was similar (35% versus 19%; p = 0.30 and 11% versus 18%; 0.54 respectively). The two-year graft function was similar with a median eGFR of 56 ml/min/1.73m(2) (range 21–128) (ATG-F-group) and 51 ml/min/1.73m(2) (range 22–132) (Thymo-group) (p = 0.69). CONCLUSION: We found no significant differences between the compared study drugs for induction treatment in immunological high-risk patients regarding safety and efficacy during follow-up with good allograft function at 2 years after transplantation.
format Online
Article
Text
id pubmed-5113896
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher Public Library of Science
record_format MEDLINE/PubMed
spelling pubmed-51138962016-12-08 A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study Burkhalter, F. Schaub, S. Bucher, Ch. Gürke, L. Bachmann, A. Hopfer, H. Dickenmann, M. Steiger, J. Binet, I. PLoS One Research Article BACKGROUND: Induction treatment with rabbit polyclonal antithymocyte globulins (ATGs) is frequent used in kidney transplant recipients with donorspecific HLA antibodies and shows acceptable outcomes. The two commonly used ATGs, Thymoglobulin and ATG-F have slightly different antigen profile and antibody concentrations. The two compounds have never been directly compared in a prospective trial in immunological high-risk recipients. Therefore we performed a prospective randomized controlled study comparing the two compounds in immunological high-risk kidney recipients in terms of safety and efficacy. METHODS: Immunological high-risk kidney recipients, defined as the presence of HLA DSA but negative CDC-B and T-cell crossmatches were randomized 1:1 to receive ATG-F or Thymoglobulin. Maintenance immunosuppressive therapy consisted of tacrolimus, mycophenolate mofetil and steroids. RESULTS: The per-protocol analysis included 35 patients. There was no immediate infusion reaction observed with both compounds. No PTLD or malignancy occurred during the follow-up in both groups. The incidence of viral and bacterial infections was similar in both groups (p = 0.62). The cumulative incidence of clinical and subclinical antibody mediated allograft rejection as well as T-cell mediated allograft rejection during the first year between ATG-F and Thymoglobulin was similar (35% versus 19%; p = 0.30 and 11% versus 18%; 0.54 respectively). The two-year graft function was similar with a median eGFR of 56 ml/min/1.73m(2) (range 21–128) (ATG-F-group) and 51 ml/min/1.73m(2) (range 22–132) (Thymo-group) (p = 0.69). CONCLUSION: We found no significant differences between the compared study drugs for induction treatment in immunological high-risk patients regarding safety and efficacy during follow-up with good allograft function at 2 years after transplantation. Public Library of Science 2016-11-17 /pmc/articles/PMC5113896/ /pubmed/27855166 http://dx.doi.org/10.1371/journal.pone.0165233 Text en © 2016 Burkhalter et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Burkhalter, F.
Schaub, S.
Bucher, Ch.
Gürke, L.
Bachmann, A.
Hopfer, H.
Dickenmann, M.
Steiger, J.
Binet, I.
A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study
title A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study
title_full A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study
title_fullStr A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study
title_full_unstemmed A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study
title_short A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study
title_sort comparison of two types of rabbit antithymocyte globulin induction therapy in immunological high-risk kidney recipients: a prospective randomized control study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5113896/
https://www.ncbi.nlm.nih.gov/pubmed/27855166
http://dx.doi.org/10.1371/journal.pone.0165233
work_keys_str_mv AT burkhalterf acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT schaubs acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT bucherch acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT gurkel acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT bachmanna acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT hopferh acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT dickenmannm acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT steigerj acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT bineti acomparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT burkhalterf comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT schaubs comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT bucherch comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT gurkel comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT bachmanna comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT hopferh comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT dickenmannm comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT steigerj comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy
AT bineti comparisonoftwotypesofrabbitantithymocyteglobulininductiontherapyinimmunologicalhighriskkidneyrecipientsaprospectiverandomizedcontrolstudy