Trial Design: FIDELIO-DKD:

Phase 3, randomised, double-blind, placebo-controlled, multicentre, clinical trial conducted in 48 countries

^{Adapted from Bakris}

• 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

• onset of kidney failure†, or
• a sustained decrease of eGFR ≥ 40% from baseline over at least 4 weeks, or
• death due to renal causes.

• 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

FIDELIO-DKD: Selected inclusion and exclusion criteria

Adapted from Bakris

Trial Design

Patient characteristics were well balanced between groups in the FIDELIO-DKD trial

Trial Design

Patients in both groups were well managed on background therapy for CKD and T2D, respectively

The trial run-in period allowed for background medical therapies to be adjusted, including adjustment of ACEi or ARB therapy to a maximum labelled dose that did not cause unacceptable side effects.

(a)At baseline, 14 patients were not treated with an ACE inhibitor or ARB;

7 patients were treated with both an ACE inhibitor and ARB

(b)Excluding heparins

(c)These agents included sodium polystyrene sulfonate, calcium polystyrene sulfonate, and potassium-binding agents

Trial Design

Planned patient population by KDIGO stratification

Adapted from KDIGO Diabetes Work Group