The European Medicines Agency (EMA) has published – for public consultation – its DRAFT Qualification opinion for GFR slope as a Surrogate Endpoint in Randomised Controlled Trials (RCT) for Chronic Kidney Disease (CKD).
Following evidence presented in a qualification opinion request – and in its discussion meeting – the EMA’s Committee for Medicinal Products for Human Use (CHMP) suggested that glomerular filtration rate (GFR) slope (which is the average rate of change in which kidneys filter blood) can be used as a surrogate endpoint for CKD progression in some trial settings for standard marketing authorisation and indication extension approvals.
The GFR slope could therefore be used to predict clinical benefit of CKD treatments when trial feasibility is an issue. However, the EMA highlighted that use of the GFR slope as a surrogate endpoint is a proposed novel method that will be able to be used in some trial settings if properly specified and assessed.
It was specified in the draft guidance: “An estimate of treatment effect on GFR slope should be based on a sufficiently long-term evaluation period within a trial, preferably three years [but] usually at least two years.”