The first treatment approved for CKD associated with T1D in 30+ years1,2

For adult patients with CKD associated with T1D

CHANGE THE COURSE

BY REDUCING UACR1

UACR reduction with KERENDIA is expected to slow CKD progression in adults with CKD associated with T1D.1
Act on elevated UACR

Elevated UACR can signal vascular endothelial dysfunction and increased risk of CKD progression in adults with T1D5,13

Unmet need
Proven efficacy

KERENDIA significantly reduced
UACR vs placebo by 25% [LSGM treatment ratio over 6 months: 0.75 (95% CI: 0.65-0.87; P=0.0001)] over
6 months on top of standard of care1,5*

UACR data
Established safety

The overall safety profile of KERENDIA in the FINE-ONE study was consistent with the adverse reactions reported
in patients with CKD associated
with T2D1

Safety profile

*Patients were required to be taking a stable dose of an ACEi or ARB as standard of care.1

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; ESKD=end-stage kidney disease; LSGM=least-squares geometric mean; T1D=type 1 diabetes; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.

Elevated UACR can detect CKD years before eGFR begins
to decline7

CKD is diagnosed by persistent elevation of UACR ≥30 mg/g or eGFR <60 mL/min/1.73 m2 for at least 3 months.8
In the FINE-ONE trial, patients were required to have a UACR ≥200 mg/g to <5000 mg/g at screening1

UACR is an independent, modifiable risk factor that can increase
10-20 years before decline in eGFR7,9*†‡

Vascular endothelial dysfunction linked to kidney damage can occur as early as

after a T1D diagnosis7,9,10

putting patients at risk early in life

Don't wait for eGFR decline when
elevated UACR can be addressed today

*Figure adapted from Afkarian M. Pediatr Nephrol. 2015.7 †UACR and eGFR provide complementary, independent information for cardiovascular risk assessment
and should be interpreted together.9 ‡Based on conceptual model.7

CKD=chronic kidney disease; eGFR=estimated glomerular filtration rate; T1D=type 1 diabetes; UACR=urine albumin-to-creatinine ratio.

KERENDIA significantly reduced UACR vs placebo over 6 months on top of standard of care1,5*

Trial design: FINE-ONE (N=242) was a randomized, double-blind, placebo-controlled, multicenter phase 3 trial in adults with CKD associated with T1D.

UACR Graph

The adjusted relative reduction in UACR comparing KERENDIA with placebo at months 3 and 6 were exploratory endpoints.
Confidence intervals are unadjusted and should not be used for inference.5

Reductions in UACR were observed as early as Month 3 and were sustained through Month 61

*Patients were required to be taking a stable dose of an ACEi or ARB as standard of care.1 †Figure adapted from Heerspink H, et al. N Engl J Med. 2026.5 ‡Up to 3 daily UACR measures were combined into a geometric mean UACR prior to the analysis of the ratio to baseline of geometric mean UACR.5

ACEi=angiotensin-converting enzyme inhibitor; ARB=angiotensin receptor blocker; BL=baseline; CI=confidence interval; CKD=chronic kidney disease; LSGM=least-squares geometric mean; T1D=type 1 diabetes; UACR=urine albumin-to-creatinine ratio.

KERENDIA was generally well-tolerated in adults with CKD associated with T1D1

The overall safety profile of KERENDIA in the FINE-ONE study was consistent with the adverse reactions reported in patients with CKD associated with T2D1

Select adverse reactions in FINE-ONE5,12

Adverse reactions in patients with CKD associated with T2D1

From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).

CKD=chronic kidney disease; T1D=type 1 diabetes; T2D=type 2 diabetes.