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Comparing CKD populations with T1D and T2D: a perspective based on the FINE-ONE and FIDELITY populations
Hiddo J L Heerspink1, Rajiv Agarwal2, Antonio J Amor3
1Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.
Insights
Chronic kidney disease (CKD) affects both type 1 and type 2 diabetes patients. Albuminuria may bridge treatment data between these groups, addressing unmet needs in type 1 diabetes CKD.
Area of Science:
- Nephrology
- Endocrinology
- Clinical Pharmacology
Background:
- Chronic kidney disease (CKD) is a prevalent comorbidity in type 1 diabetes (T1D) and type 2 diabetes (T2D), increasing mortality and cardiovascular risk.
- Standard treatments for CKD in T1D, including renin-angiotensin system inhibitors and glycemic control, leave a residual risk of disease progression.
- Therapeutic advancements for CKD in T1D have lagged significantly behind those for T2D, highlighting an unmet clinical need.
Purpose of the Study:
- To compare the epidemiology, pathophysiology, and clinical characteristics of CKD in T1D versus T2D populations.
- To explore the utility of albuminuria as a bridging biomarker for extrapolating treatment evidence between T1D and T2D populations with CKD.
- To inform the potential translation of finerenone's efficacy from T2D to T1D based on trial data similarities.
Main Methods:
- Comparative analysis of epidemiological, pathophysiological, and clinical data between T1D-CKD and T2D-CKD cohorts.
- Evaluation of albuminuria as a potential biomarker to bridge clinical findings across diabetes types.
- Review of the FINE-ONE trial (finerenone in T1D-CKD) and comparison with FIDELITY data (finerenone in T2D-CKD).
Main Results:
- Similarities in CKD presentation and progression between T1D and T2D populations are anticipated.
- Albuminuria is proposed as a key biomarker to facilitate evidence extrapolation.
- The FINE-ONE trial utilizes albuminuria change as a primary endpoint, enabling comparison with T2D data.
Conclusions:
- Understanding the similarities and differences between T1D-CKD and T2D-CKD is crucial for advancing treatment.
- Albuminuria holds promise as a bridging biomarker to accelerate therapeutic development for CKD in T1D.
- Finerenone's efficacy in T2D-CKD may be translatable to T1D-CKD, pending further investigation via trials like FINE-ONE.
Abstract:
Chronic kidney disease (CKD) is a common comorbidity of both type 1 diabetes (T1D) and type 2 diabetes (T2D) and is associated with increased mortality, end-stage kidney disease and cardiovascular disease risk. Despite standard-of-care treatment with renin-angiotensin system inhibitors added to blood pressure and glycaemic control, people with CKD and T1D have a residual risk of CKD progression. Advances in therapeutic management have been limited over the past 3 decades, especially compared with CKD in T2D, for which new treatment options have emerged in the last 5 years. In this review article we discuss the similarities and differences between T1D and T2D populations with CKD, including epidemiology, pathophysiology and clinical findings. Additionally, we explore the use of albuminuria as a potential bridging biomarker to extrapolate clinical evidence from one population to the other. This concept could offer a promising strategy to narrow the gap in treatment availability between these populations and address the unmet therapeutic need in people with CKD and T1D. The FINE-ONE trial is investigating the non-steroidal mineralocorticoid receptor antagonist finerenone in a population with CKD and T1D using the change in urine albumin:creatinine ratio from baseline over 6 months as its primary endpoint and bridging biomarker. Similarities between the populations from FINE-ONE trial and FIDELITY (a pooled dataset of individuals with CKD and T2D included in two large phase 3 clinical trials of finerenone) may inform the translation of clinical evidence on finerenone from people with CKD and T2D to those with CKD and T1D.
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