FIDELIO-DKD Trial Design
FIDELIO-DKD is a Phase 3, randomised, double-blind, placebo-controlled, multicentre, clinical trial conducted in 48 countries
Adapted from Bakris
At baseline:
- 87.5%of patients had UACR levels ≥300 mg/g at baseline
- 99.9%of patients received a tolerated dose of an ACEi or ARB
- 97.4%of patients used glucose-lowering medication
The primary renal outcome was the time to the first occurrence of the composite endpoint of:
- onset of kidney failure†, or
- a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or
- death due to renal causes.
The secondary cardiovascular outcome was the time to first occurrence of the composite endpoint of:
- CV death, or
- non-fatal MI, or
- non-fatal stroke, or
- hospitalisation for HF
*Includes an ACEi or ARB at the maximum tolerated dose.
†Defined as end-stage kidney disease (initiation of dialysis for ≥90 days or kidney transplantation) or an eGFR <15 mL/min/1.73 m2 over ≥4 weeks.
Trial Design
Planned patient population by KDIGO stratification
Bluelow risk (if no other markers of kidney disease, no CKD)
Yellowmoderately increased risk
Orangehigh risk
Redvery high risk
Adapted from KDIGO Diabetes Work Group
ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; CV=cardiovascular; DKD=diabetic kidney disease; DPP-4=dipeptidyl peptidase-4; eGFR=estimated glomerular filtration rate; GFR=glomerular filtration rate; GLP-1=glucagon-like peptide-1; HbA1c=glycated haemoglobin; HF=heart failure; KDIGO=Kidney Disease: Improving Global Outcomes; MI=myocardial infarction; MOD=mechanism of disease; MOA=mechanism of action; OD=once daily; RAAS=renin-angiotensin-aldosterone system; SGLT2=sodium-glucose cotransporter 2; T2D=type 2 diabetes: UACR=urine albumin-to-creatinine ratio.
PP-KER-GB-0471 | March 2024