Clinical trial design and endpoints in kidney transplantation

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EXECUTIVE SUMMARY

Published on 20 May 2022

Redefining Risk Stratification and Endpoints for Clinical Trials in Kidney Transplantation: Rationale and Methodology of Proposals Submitted to the European Medicines Agency by the European Society for Organ Transplantation

Maarten Naesens
Stefan Schneeberger
the ESOT Working Group
Maarten Naesens
Jan Ulrich Becker
Maria Irene Bellini
Oriol Bestard
Georg A. Böhmig
Klemens Budde
23 more
Allison Tong

doi 10.3389/ti.2021.10142

1 citation

CONSENSUS REPORT

Published on 20 May 2022

Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials

Jan Ulrich Becker
Daniel Seron
Marion Rabant
Candice Roufosse
Maarten Naesens

doi 10.3389/ti.2022.10141

12 citations

CONSENSUS REPORT

Published on 20 May 2022

Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation

Daniel Seron
Marion Rabant
Jan Ulrich Becker
Candice Roufosse
Maria Irene Bellini
Georg A. Böhmig
Klemens Budde
Fritz Diekmann
Denis Glotz
5 more
Maarten Naesens

doi 10.3389/ti.2022.10135

14 citations

CONSENSUS REPORT

Published on 20 May 2022

Allograft Function as Endpoint for Clinical Trials in Kidney Transplantation

Luuk Hilbrands
Klemens Budde
Maria Irene Bellini
Fritz Diekmann
Lucrezia Furian
Josep Grinyó
Uwe Heemann
Dennis A. Hesselink
Alexandre Loupy
4 more
Maarten Naesens

doi 10.3389/ti.2022.10139

15 citations

CONSENSUS REPORT

Published on 20 May 2022

Surrogate Endpoints for Late Kidney Transplantation Failure

Maarten Naesens
Klemens Budde
Luuk Hilbrands
Rainer Oberbauer
Maria Irene Bellini
Denis Glotz
Josep Grinyó
Uwe Heemann
Ina Jochmans
3 more
Alexandre Loupy

doi 10.3389/ti.2022.10136

25 citations

CONSENSUS REPORT

Published on 20 May 2022

Alloimmune Risk Stratification for Kidney Transplant Rejection

Oriol Bestard
Olivier Thaunat
Maria Irene Bellini
Georg A. Böhmig
Klemens Budde
Frans Claas
Lionel Couzi
Lucrezia Furian
Uwe Heemann
4 more
Maarten Naesens

doi 10.3389/ti.2022.10138

16 citations

CONSENSUS REPORT

Published on 20 May 2022

Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions

Allison Tong
Rainer Oberbauer
Maria Irene Bellini
Klemens Budde
Fergus J. Caskey
Fabienne Dobbels
Liset Pengel
Lionel Rostaing
Stefan Schneeberger
Maarten Naesens

doi 10.3389/ti.2022.10134

19 citations

CONSENSUS REPORT

Published on 20 May 2022

Proposed Definitions of Antibody-Mediated Rejection for Use as a Clinical Trial Endpoint in Kidney Transplantation

Candice Roufosse
Jan Ulrich Becker
Marion Rabant
Daniel Seron
Maria Irene Bellini
Georg A. Böhmig
Klemens Budde
Fritz Diekmann
Denis Glotz
5 more
Maarten Naesens

doi 10.3389/ti.2022.10140

8 citations

CONSENSUS REPORT

Published on 20 May 2022

Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation

Maarten Naesens
Alexandre Loupy
Luuk Hilbrands
Rainer Oberbauer
Maria Irene Bellini
Denis Glotz
Josep Grinyó
Uwe Heemann
Ina Jochmans
3 more
Klemens Budde

doi 10.3389/ti.2022.10137

11 citations

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Articles

Redefining Risk Stratification and Endpoints for Clinical Trials in Kidney Transplantation: Rationale and Methodology of Proposals Submitted to the European Medicines Agency by the European Society for Organ Transplantation

Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials

Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation

Allograft Function as Endpoint for Clinical Trials in Kidney Transplantation

Surrogate Endpoints for Late Kidney Transplantation Failure

Alloimmune Risk Stratification for Kidney Transplant Rejection

Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions

Proposed Definitions of Antibody-Mediated Rejection for Use as a Clinical Trial Endpoint in Kidney Transplantation

Rationale for Surrogate Endpoints and Conditional Marketing Authorization of New Therapies for Kidney Transplantation

Transplant International