MO475: Dapa-CKD Patient Profile: Transposability Assessment in Real-Life Through the CKD-Rein French Cohort

The objective of this observational study was to describe the `DAPA-CKD-like’ population and to assess the burden of illness (comorbidities, cardiovascular (CV) and renal events) and prognosis in patients with CKD in France, compared with those randomized in the DAPA-CKD RCT [1].

The CKD-REIN cohort study enrolled 3033 patients with moderate or advanced CKD from 40 nationally representative nephrology clinics in France [median age of 68 (IQR: 60–76), min-max: 19–94, 65% men, CKD stage 3 (60%) or 4 (40%)]. Inclusions started in July 2013 and ended in July 2016. The analysis describes baseline characteristics of patients with DAPA-CKD inclusion criteria (75 ≥ eGFR ≥ 25 mL/min/1.73 m² and 5000 ≥ UACR ≥ 200 mg/g) and CV and renal outcomes >3-year follow-up.

Among the 3033 adult patients included in CKD-REIN cohort, 503 met the inclusion and exclusion criteria of the DAPA-CKD RCT. The characteristics of these 503 French `DAPA-CKD-like’ patients and those of the DAPA-CKD RCT were similar in terms of age (63.9 ± 13.6 versus 61.8 ± 12.1), gender (74% men versus 67%), eGFR (36.5 ± 9.1 mL/min/1.73 m² versus 43.1 ± 12.4 mL/min/1.73 m²) and SBP (145 ± 21 mmHg versus 137 ± 17 mmHg). The CV and renal event rates/100 patient-year (PY) were similar between the two populations, both for the main composite outcome (eGFR decline ≥50% or end-stage kidney disease (defined as eGFR <15 mL/min/1.73 m² long-term dialysis or kidney transplantation) or CV or renal deaths), 7.9/100 PY versus 7.5/100 PY, but also for each outcome of the main endpoint and secondary endpoints.

In conclusion, the DAPA-CKD RCT patient profile appears to be similar to a real-life French CKD patient profile based on the French CKD-REIN cohort meeting the inclusion and exclusion criteria of the DAPA-CKD RCT.