KI publishes ISN’s International Consensus Definitions of Clinical Trial Outcomes for Kidney Failure: 2020
Kidney International has published the International Consensus Definitions of Clinical Trial Outcomes for Kidney Failure: 2020, developed from the 1st International Consensus Meeting on Defining Kidney Failure in Clinical Trials hosted by the ISN in Vancouver, BC, Canada, in early 2020.
Kidney failure is an important outcome for patients, clinicians, researchers, healthcare systems, payers, and regulators. However, no harmonized international consensus definitions of kidney failure and key surrogates of progression to kidney failure exist specifically for clinical trials. Consequently, the ISN convened an international multi-stakeholder meeting to develop consensus on this topic.
The consensus of the meeting participants was that clinical trial kidney failure outcomes should be comprised of a composite that includes: receipt of a kidney transplant, initiation of maintenance dialysis, death from kidney failure, and may also include outcomes based solely on laboratory measurements of glomerular filtration rate (GFR)- a sustained low GFR and a sustained percent decline in GFR. The final definitions reflect the consensus for use in clinical trials. Details are discussed in the report, which also lists the multi-stakeholder participants.
This was the first attempt by the international nephrology community to identify reproducible, robust definitions of kidney failure outcomes and acceptable surrogates for clinical trials to be used worldwide, in any resource setting. The value of these consensus definitions is to improve consistency and understanding of results in clinical trials and to improve the evidence base from which to treat patients with kidney diseases worldwide.
This initiative is part of ISN’s recognition of the importance of clinical research and the need to enhance clinical trials based on established endpoints with international relevance. Consider supporting our work by becoming an ISN member.
Best Regards,
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| Vivek Jha ISN President |
Adeera Levin ISN Research working group Chair |
Masaomi Nangaku ISN Research working group Co-chair |
