Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes

Transpl Int. 2023 Sep 25:36:11951. doi: 10.3389/ti.2023.11951. eCollection 2023.

Abstract

New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant. Critical Path Institute's Transplant Therapeutics Consortium received a qualification opinion for the iBOX Scoring System as a novel secondary efficacy endpoint for kidney transplant clinical trials through European Medicines Agency's qualification of novel methodologies for drug development. This is the first qualified endpoint for any transplant indication and is now available for use in kidney transplant clinical trials. Although the current efficacy failure endpoint has typically shown the noninferiority of therapeutic regimens, the iBOX Scoring System can be used to demonstrate the superiority of a new immunosuppressive therapy compared to the standard of care from 6 months to 24 months posttransplant in pivotal or exploratory drug therapeutic studies.

Keywords: iBox; kidney transplant; organ transplant; transplant clinical trial; transplant outcomes.

MeSH terms

  • Graft Rejection / prevention & control
  • Humans
  • Immunosuppression Therapy
  • Immunosuppressive Agents / therapeutic use
  • Kidney Transplantation*

Substances

  • Immunosuppressive Agents

Grants and funding

Critical Path Institute is supported by the FDA of the US Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by nongovernment sources, totaling $11,196,634. TTC is supported by funds from the transplant community, including the biopharmaceutical and diagnostic industries, professional societies, and regulatory agencies, combined with support from academic institutions, ensuring that people living with a transplant are at the core of all we do.