Overview of the FIDELITY Pooled Analytics Design

ESC Congress 2021: Updates on Chronic Kidney Disease, Heart Failure and Type 2 Diabetes – Episode 3

An overview of the FIDELITY analysis, which pooled data from the FIGARO-DKD and FIDELIO-DKD trials in patients with type 2 diabetes and CRF.


Rajiv Agarwal, MD, MS: FIDELITY is not an essay, it is an analysis. This is a grouped analysis at the individual level that has been predefined. We have pre-specified that we would take all the data from FIDELIO-DKD and FIGARO-DKD, and pool them to arrive at the results that interest us: kidney results and cardiovascular results. Together we have 13,171 patients from 48 countries at over 1000 sites who participated in the 2 trials, as a population randomized to receive finerenone or a placebo. The follow-up is 3 years, median duration. So we have many years of follow-up in this trial, and we take everyone who has an optimized ACE [angiotensin-converting enzyme inhibitor] or ARA [angiotensin receptor blocker]. They all have type 2 diabetes and CKD [chronic kidney disease].

They all have a serum potassium of 4.8 mmol / L or less at baseline and during the test. But remember after the break-in period we have a 2 week gap between that and randomization. Many patients during this time may have an increase in potassium, and it doesn’t matter – they could still be randomized to one of the two treatments. Several times we had potassium levels over 5 mmol / L in the test. They were always included in the randomization scheme. We excluded patients with symptomatic HFrEF [heart failure with reduced ejection fraction]. We pre-specified the cardiovascular composite in the FIDELITY analysis, which was the same as previously in the FIGARO trial. There is a 4-point MACE [major adverse cardiac event] full stop, which is CV [cardiovascular] death, non-fatal MI [myocardial infarction], non-fatal stroke and hospitalization for heart failure.

We also have the kidney composite, which represents a 57% drop in eGFR [estimated glomerular filtration rate]; renal failure, eGFR less than 15 and dialysis; or death from kidney failure. These are the 2 results we set, and now we can really analyze people who have stage 1 to 4 kidney disease and albuminuria ranging from 30 to 5000 mg / g: almost all the patients nephrologists typically see. Patients who are not included are people who have an eGFR less than 25 and who do not have albuminuria in this trial. The strength of this analysis allows you to group together and examine the effects on cardiovascular and renal failure outcomes in this very large population.

Transcription edited for clarity.

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