CKD Chronic Kidney Disease / Diabetes Mellitus Type 2 · Observational Study

Evaluation of the Risk of Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned computational modelling study comparing finerenone monotherapy versus finerenone plus empagliflozin in a simulated cohort of 50,000 patients with CKD and type 2 diabetes. No results have been posted to the registry. The study will use artificial intelligence to generate a synthetic population based on real trial data and model 10-year risks of heart failure, cardiovascular death, and kidney disease progression.

What was studied

Observational. CKD - Chronic Kidney Disease, Diabetes Mellitus Type 2. Intervention: Reference Monotherapy; Early Combo Strategy. Compared with: Finerenone monotherapy (reference therapy). n = 50,000.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This is a planning-stage study with no clinical results yet available. Readers should not use this record to inform practice decisions until results are posted and the validity of the synthetic model has been independently evaluated.

Plain-language summary

This is a planned computer simulation study with no results reported; it uses synthetic data based on prior trials to model comparative outcomes of drug combinations in a virtual population.

Study design

As stated by the source record.

MethodsOther model. Prospective time perspective. Primary outcome measures: Time to First Occurrence of Incident Heart Failure, Heart Failure Hospitalization, or Cardiovascular Death (assessed at From the beginning of the simulation up to 10 years); Time to Onset of End-Stage Kidney Disease, Sustained eGFR <15 ml/min/1.73 m², or ≥40-57% Decline in eGFR from Baseline (assessed at From the beginning of the simulation up to 10 years)

DesignObservational

PopulationCKD - Chronic Kidney Disease, Diabetes Mellitus Type 2

Sample size50,000

InterventionReference Monotherapy; Early Combo Strategy

ComparatorFinerenone monotherapy (reference therapy)

Reported figures

Quoted from the source exactly as published.

Planned enrollment50000

Primary outcome measure 1Time to First Occurrence of Incident Heart Failure, Heart Failure Hospitalization, or Cardiovascular Death from beginning of simulation up to 10 years

Primary outcome measure 2Time to Onset of End-Stage Kidney Disease, Sustained eGFR <15 ml/min/1.73 m², or ≥40-57% Decline in eGFR from Baseline from beginning of simulation up to 10 years

Clinical bottom line

Caveats

No results reported; recruitment has not yet begun.
Study uses synthetic data generated by artificial intelligence, not real-world observational or trial data.
Validation methods for the simulation model are not described in the registry record.
Generalisability of findings from a synthetic cohort to actual clinical populations is not established.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Observational computer simulation; no human participants or real-world data collection.

Directness

limited

Synthetic population modelled from prior trial data; outcomes assessed in silico, not clinically.

Consistency

insufficient

No results posted; cannot assess consistency with other evidence.

Risk of bias

insufficient

Simulation methodology and validation criteria not described in registry record.

Sample adequacy

limited

Estimated 50,000 synthetic participants; generalisability to real patients unknown.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07719621). This is a study registration, not published results. Lead sponsor: Aeterna Medical Solutions SL. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 50000 participants (ESTIMATED). Conditions: CKD - Chronic Kidney Disease, Diabetes Mellitus Type 2. Primary outcome measures: Time to First Occurrence of Incident Heart Failure, Heart Failure Hospitalization, or Cardiovascular Death , From the beginning of the simulation up to 10 years; Time to Onset of End-Stage Kidney Disease, Sustained eGFR <15 ml/min/1.73 m², or ≥40-57% Decline in eGFR from Baseline , From the beginning of the simulation up to 10 years. Brief summary: The goal of this study, performed entirely with computer programs, is to learn if using a combination of two drugs works better than using one alone, in the treatment of people with chronic kidney disease and type 2 diabetes mellitus. The main questions it aims to answer are: * How many events of heart failure, heart failure hospitalizations, and cardiovascular death happen in each group? * How do serious kidney problems progress in each of the groups? Researchers will compare reference therapy (finerenone) with a combination of finerenone and empagliflozin. There will not be human participants in this study. With the help of artificial intelligence, researchers will recreate a large population of people with chronic kidney disease and type 2 diabetes mellitus. Data on their disease, treatment, and laboratory parameters will be based on and simulated using real data from previous clinical trials conducted with real participants.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07719621CKD Chronic Kidney DiseaseAeterna Medical Solutions SLDiabetes Mellitus Type 2