Stronger together: Lessons from the iBox qualification process

Article Surgery

Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes

Amanda Klein et al.

Summary: New immunosuppressive therapies are needed for kidney transplant to improve long-term graft survival. The iBOX Scoring System has received qualification as a novel endpoint for kidney transplant clinical trials, allowing it to be used to demonstrate the superiority of new immunosuppressive therapies compared to standard care.

AMERICAN JOURNAL OF TRANSPLANTATION (2023)

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Article Surgery

Surrogate Endpoints for Late Kidney Transplantation Failure

Maarten Naesens et al.

Summary: Late graft failure in kidney transplant recipients is often multifactorial, and the primary endpoints of kidney transplantation studies focus on short-term efficacy and safety of clinical interventions. Short-term improvements in specific aspects of graft function or rejection rates may not necessarily lead to meaningful long-term graft survival benefits, and combining multiple factors into a well-validated model is more likely to predict long-term outcomes. Consideration of conditional marketing authorization for therapies aiming to improve long-term outcomes following kidney transplantation highlights the need for clearer definitions of surrogate endpoints in clinical trial settings.

TRANSPLANT INTERNATIONAL (2022)

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Article Surgery

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

Daniel Seron et al.

Summary: The diagnosis of acute T cell-mediated rejection (aTCMR) is important for research and clinical treatment purposes. This paper reviews the history and classifications of TCMR and discusses its potential role in clinical trials. There is variability and ambiguity in the clinical monitoring and management of aTCMR, and further research is needed to improve treatment outcomes.

TRANSPLANT INTERNATIONAL (2022)

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Article Urology & Nephrology

Exploring the Complexity of Death-Censored Kidney Allograft Failure

Manuel Mayrdorfer et al.

Summary: The study found that kidney graft loss is often caused by multiple factors and more complex than previously thought, including intercurrent medical events, T cell-mediated rejection, and antibody-mediated rejection; the primary cause is often antibody-mediated rejection.

JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY (2021)

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Article Surgery