CKD - Chronic Kidney DiseaseNCT07719621
Evaluation of the Risk of Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
An observational study of CKD - Chronic Kidney Disease and Diabetes Mellitus Type 2, run by Aeterna Medical Solutions SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CKD - Chronic Kidney Disease, Diabetes Mellitus Type 2
- How many people
- 100,000 participants
- Where
- 1 siteSpain
- Study dates
- 7 Aug 2026to 20 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A massive synthetic cohort (N = 50,000 to 100,000 virtual subjects) will be structured and parameterized to faithfully reproduce the characteristics of the reference population, using a four-phase instantiation framework designed to ensure biological plausibility. Each virtual patient will be cloned to experience both treatment trajectories simultaneously, acting as their own absolute control and eliminating inter-individual variability bias.
Inclusion Criteria: The same characteristics of the reference population: CONFIDENCE trial (NCT05254002). In brief:
- Patients with chronic kidney disease (eGFR 30-90 ml/min/1.73 m²)
- Persistent albuminuria (UACR 100-5000 mg/g)
- Type 2 diabetes mellitus (T2D) under stable blockade of the renin-angiotensin system (ACEi/ARB)
Exclusion Criteria: The same characteristics of the reference population: CONFIDENCE trial (NCT05254002). In brief:
- Participants with type 1 diabetes (T1D).
- Participant with hepatic insufficiency classified as Child-Pugh C.
- Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implication of Albuminuria Reduction and Other Cardiorenal Effects on The Risk of Heart Failure in Patients With CKD and T2D
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:
Read more
- 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.
Read the detailed description
Traditional risk stratification tools, such as the PREVENT (Predicting Risk of cardiovascular disease EVENTs) equations, estimate 10-year risk using static baseline variables. Simply adjusting the UACR input in the PREVENT calculator offers only a crude approximation and does not capture the dynamic, nonlinear effects of ongoing pharmacological treatment, biological hysteresis, and competing risks. To address these limitations, we will develop a high-fidelity digital twin simulation framework powered by the Aeterna Deep computational engine. This in silico trial will project 10-year cardio-renal outcomes for finerenone, empagliflozin, and their combination, while quantifying the mechanistic contribution of UACR reduction relative to other cardio-renal factors. The reference population will be defined according to the CONFIDENCE trial criteria, including adults with chronic kidney disease (eGFR 30-90 ml/min/1.73 m²), type 2 diabetes, and persistent albuminuria (UACR 100-5000 mg/g), receiving maximally tolerated renin-angiotensin system inhibitors. From this base, a synthetic cohort of 100,000 digital twins will be constructed using a four phase instantiation framework designed to ensure biological plausibility. First, marginal distributions for key demographic and clinical variables (age, sex, eGFR, UACR, blood pressure, HbA1c) will be parameterized from validated real-world datasets. Second, nonlinear physiological interdependencies will be reconstructed through multivariate coupling functions to preserve the in vivo covariance structure. Third, individual phenotypes will be generated via high-dimensional stochastic sampling to capture the full range of cardio renal metabolic trajectories. Finally, all instantiated profiles will undergo thermodynamic and biophysical truncation, whereby parameter combinations violating conservation principles or exceeding human homeostatic limits will be excluded and regenerated, ensuring that only physiologically viable digital entities will be retained for downstream analyses.
- Keywords
- Chronic Kidney Disease, Diabetes Mellitus Type 2, finerenone, empagliflozin
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Reference Monotherapy | Finerenone | |
| Early Combo Strategy | Concomitant combination of finerenone and empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Occurrence of Incident Heart Failure, Heart Failure Hospitalization, or Cardiovascular Death
Composite endpoint including incident heart failure, heart failure hospitalization, and cardiovascular death. Purely atherothrombotic events (myocardial infarction and ischemic stroke) are excluded from this composite variable.
Measured: 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
Composite renal endpoint defined as time to end-stage kidney disease (ESKD), sustained decline in eGFR below 15 ml/min/1.73 m², or an irreversible decline ≥40-57% from baseline.
Measured: From the beginning of the simulation up to 10 years
Secondary outcomes (4)
Number of Participants with Non-fatal Acute Myocardial Infarction
Monitoring of non-fatal acute myocardial infarction events as an exploratory atherothrombotic outcome.
Measured: From the beginning of the simulation up to 10 years
Number of Participants with Non-fatal Ischemic Stroke
Monitoring of non-fatal ischemic stroke events as an exploratory atherothrombotic outcome.
Measured: From the beginning of the simulation up to 10 years
Annual Rate of Change in Estimated Glomerular Filtration Rate (eGFR) (ml/min/1.73 m²/year)
Determination of the annual eGFR slope, separating the acute phase of the initial dip from chronic stabilization.
Measured: From the beginning of the simulation up to 10 years
Proportion of Participants with Transition Between Albuminuria Stages (Normo-, Micro-, Macroalbuminuria)
Analysis of albuminuria stage transition, including regression or progression rates among normo-, micro-, and macroalbuminuria compartments.
Measured: From the beginning of the simulation up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start7 Aug 2026
- Primary completion15 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for CKD - Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeterna Medical Solutions SL
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer Hispania, S.L
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719621
- Sponsor's protocol ID
- HF_CKD_T2D001
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Because all participants will be virtual
Publications
Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
PubMed 26378978Silva A, Vale N. Digital Twins in Personalized Medicine: Bridging Innovation and Clinical Reality. J Pers Med. 2025 Oct 22;15(11):503. doi: 10.3390/jpm15110503.
PubMed 41295204Corral-Acero J, Margara F, Marciniak M, Rodero C, Loncaric F, Feng Y, Gilbert A, Fernandes JF, Bukhari HA, Wajdan A, Martinez MV, Santos MS, Shamohammdi M, Luo H, Westphal P, Leeson P, DiAchille P, Gurev V, Mayr M, Geris L, Pathmanathan P, Morrison T, Cornelussen R, Prinzen F, Delhaas T, Doltra A, Sitges M, Vigmond EJ, Zacur E, Grau V, Rodriguez B, Remme EW, Niederer S, Mortier P, McLeod K, Potse M, Pueyo E, Bueno-Orovio A, Lamata P. The 'Digital Twin' to enable the vision of precision cardiology. Eur Heart J. 2020 Dec 21;41(48):4556-4564. doi: 10.1093/eurheartj/ehaa159.
PubMed 32128588Viceconti M, Henney A, Morley-Fletcher E. In silico clinical trials: how computer simulation will transform the biomedical industry. Int J Clin Trials. 2016;3(2):37-46. Doi: 10.18203/2349-3259.ijct20161408
Heerspink HJL, Greene T, Tighiouart H, Gansevoort RT, Coresh J, Simon AL, Chan TM, Hou FF, Lewis JB, Locatelli F, Praga M, Schena FP, Levey AS, Inker LA; Chronic Kidney Disease Epidemiology Collaboration. Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomised clinical trials. Lancet Diabetes Endocrinol. 2019 Feb;7(2):128-139. doi: 10.1016/S2213-8587(18)30314-0. Epub 2019 Jan 8.
PubMed 30635226Inker LA, Heerspink HJL, Tighiouart H, Levey AS, Coresh J, Gansevoort RT, Simon AL, Ying J, Beck GJ, Wanner C, Floege J, Li PK, Perkovic V, Vonesh EF, Greene T. GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Meta-Analysis of Treatment Effects of Randomized Controlled Trials. J Am Soc Nephrol. 2019 Sep;30(9):1735-1745. doi: 10.1681/ASN.2019010007. Epub 2019 Jul 10.
PubMed 31292197Holtkamp F, Gudmundsdottir H, Maciulaitis R, Benda N, Thomson A, Vetter T. Change in Albuminuria and Estimated GFR as End Points for Clinical Trials in Early Stages of CKD: A Perspective From European Regulators. Am J Kidney Dis. 2020 Jan;75(1):6-8. doi: 10.1053/j.ajkd.2019.07.019. Epub 2019 Oct 28. No abstract available.
PubMed 31672251Bansal N, Katz R, Robinson-Cohen C, Odden MC, Dalrymple L, Shlipak MG, Sarnak MJ, Siscovick DS, Zelnick L, Psaty BM, Kestenbaum B, Correa A, Afkarian M, Young B, de Boer IH. Absolute Rates of Heart Failure, Coronary Heart Disease, and Stroke in Chronic Kidney Disease: An Analysis of 3 Community-Based Cohort Studies. JAMA Cardiol. 2017 Mar 1;2(3):314-318. doi: 10.1001/jamacardio.2016.4652.
PubMed 28002548Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB Sr, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PWF. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2935-2959. doi: 10.1016/j.jacc.2013.11.005. Epub 2013 Nov 12. No abstract available.
PubMed 24239921Abdullah M, Khalid N, Frishman WH, Aronow WS. Finerenone and Empagliflozin in Type 2 Diabetes. Cardiol Rev. 2026 May 11. doi: 10.1097/CRD.0000000000001308. Online ahead of print.
PubMed 42108478Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.
PubMed 40470996Geraci G, Sinatra N, Paterno V, Calabrese V, Cassataro G, Cuttone G, Geraci C, Esposito R, Mancusi C, Pucci G, Zanoli L, Mule G, Polosa R, Ferrara P, Carollo C. Finerenone in Cardiorenal Disease: A Narrative Review of Molecular Mechanisms, Clinical Evidence, and Emerging Therapeutic Roles. Cardiovasc Drugs Ther. 2026 May 22. doi: 10.1007/s10557-026-07890-7. Online ahead of print.
PubMed 42171960Rossing P, Anker SD, Filippatos G, Pitt B, Ruilope LM, Birkenfeld AL, McGill JB, Rosas SE, Joseph A, Gebel M, Roberts L, Scheerer MF, Bakris GL, Agarwal R; FIDELIO-DKD and FIGARO-DKD Investigators. Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium-Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis. Diabetes Care. 2022 Dec 1;45(12):2991-2998. doi: 10.2337/dc22-0294.
PubMed 35972218The EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, Green JB, Hauske SJ, Emberson JR, Preiss D, Judge P, Mayne KJ, Ng SYA, Sammons E, Zhu D, Hill M, Stevens W, Wallendszus K, Brenner S, Cheung AK, Liu ZH, Li J, Hooi LS, Liu W, Kadowaki T, Nangaku M, Levin A, Cherney D, Maggioni AP, Pontremoli R, Deo R, Goto S, Rossello X, Tuttle KR, Steubl D, Petrini M, Massey D, Eilbracht J, Brueckmann M, Landray MJ, Baigent C, Haynes R. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023 Jan 12;388(2):117-127. doi: 10.1056/NEJMoa2204233. Epub 2022 Nov 4.
PubMed 36331190Dutka M, Bobinski R, Ulman-Wlodarz I, Hajduga M, Bujok J, Pajak C, Cwiertnia M. Sodium glucose cotransporter 2 inhibitors: mechanisms of action in heart failure. Heart Fail Rev. 2021 May;26(3):603-622. doi: 10.1007/s10741-020-10041-1. Epub 2020 Nov 4.
PubMed 33150520
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implication of Albuminuria Reduction and Other Cardiorenal Effects on The Risk of Heart Failure in Patients With CKD and T2D
- ClinicalTrials.gov ID
- NCT07719621
- Acronym / sponsor ID
- HF_CKD_T2D001
- Keywords
- Chronic Kidney Disease, Diabetes Mellitus Type 2, finerenone, empagliflozin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100,000 participants (actual)
- Lead sponsor
- Aeterna Medical Solutions SLUniversity, hospital or other
- Collaborators
- Bayer Hispania, S.L
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Traditional risk stratification tools, such as the PREVENT (Predicting Risk of cardiovascular disease EVENTs) equations, estimate 10-year risk using static baseline variables. Simply adjusting the UACR input in the PREVENT calculator offers only a crude approximation and does not capture the dynamic, nonlinear effects of ongoing pharmacological treatment, biological hysteresis, and competing risks. To address these limitations, we will develop a high-fidelity digital twin simulation framework powered by the Aeterna Deep computational engine. This in silico trial will project 10-year cardio-renal outcomes for finerenone, empagliflozin, and their combination, while quantifying the mechanistic contribution of UACR reduction relative to other cardio-renal factors. The reference population will be defined according to the CONFIDENCE trial criteria, including adults with chronic kidney disease (eGFR 30-90 ml/min/1.73 m²), type 2 diabetes, and persistent albuminuria (UACR 100-5000 mg/g), receiving maximally tolerated renin-angiotensin system inhibitors. From this base, a synthetic cohort of 100,000 digital twins will be constructed using a four phase instantiation framework designed to ensure biological plausibility. First, marginal distributions for key demographic and clinical variables (age, sex, eGFR, UACR, blood pressure, HbA1c) will be parameterized from validated real-world datasets. Second, nonlinear physiological interdependencies will be reconstructed through multivariate coupling functions to preserve the in vivo covariance structure. Third, individual phenotypes will be generated via high-dimensional stochastic sampling to capture the full range of cardio renal metabolic trajectories. Finally, all instantiated profiles will undergo thermodynamic and biophysical truncation, whereby parameter combinations violating conservation principles or exceeding human homeostatic limits will be excluded and regenerated, ensuring that only physiologically viable digital entities will be retained for downstream analyses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Monotherapy | – | –Finerenone |
| Early Combo Strategy | – | –Concomitant combination of finerenone and empagliflozin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A massive synthetic cohort (N = 50,000 to 100,000 virtual subjects) will be structured and parameterized to faithfully reproduce the characteristics of the reference population, using a four-phase instantiation framework designed to ensure biological plausibility. Each virtual patient will be cloned to experience both treatment trajectories simultaneously, acting as their own absolute control and eliminating inter-individual variability bias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to First Occurrence of Incident Heart Failure, Heart Failure Hospitalization, or Cardiovascular Death
Time frame: From the beginning of the simulation up to 10 years
Composite endpoint including incident heart failure, heart failure hospitalization, and cardiovascular death. Purely atherothrombotic events (myocardial infarction and ischemic stroke) are excluded from this composite variable.
Time to Onset of End-Stage Kidney Disease, Sustained eGFR <15 ml/min/1.73 m², or ≥40-57% Decline in eGFR from Baseline
Time frame: From the beginning of the simulation up to 10 years
Composite renal endpoint defined as time to end-stage kidney disease (ESKD), sustained decline in eGFR below 15 ml/min/1.73 m², or an irreversible decline ≥40-57% from baseline.
4 secondary outcomes
Number of Participants with Non-fatal Acute Myocardial Infarction
Time frame: From the beginning of the simulation up to 10 years
Number of Participants with Non-fatal Ischemic Stroke
Time frame: From the beginning of the simulation up to 10 years
Annual Rate of Change in Estimated Glomerular Filtration Rate (eGFR) (ml/min/1.73 m²/year)
Time frame: From the beginning of the simulation up to 10 years
Proportion of Participants with Transition Between Albuminuria Stages (Normo-, Micro-, Macroalbuminuria)
Time frame: From the beginning of the simulation up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 26378978Zinman B, Wanner C, Lachin JM, Fitchett D, Bluhmki E, Hantel S, Mattheus M, Devins T, Johansen OE, Woerle HJ, Broedl UC, Inzucchi SE; EMPA-REG OUTCOME Investigators. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. doi: 10.1056/NEJMoa1504720. Epub 2015 Sep 17.
- Background: PubMed 41295204Silva A, Vale N. Digital Twins in Personalized Medicine: Bridging Innovation and Clinical Reality. J Pers Med. 2025 Oct 22;15(11):503. doi: 10.3390/jpm15110503.
- Background: PubMed 32128588Corral-Acero J, Margara F, Marciniak M, Rodero C, Loncaric F, Feng Y, Gilbert A, Fernandes JF, Bukhari HA, Wajdan A, Martinez MV, Santos MS, Shamohammdi M, Luo H, Westphal P, Leeson P, DiAchille P, Gurev V, Mayr M, Geris L, Pathmanathan P, Morrison T, Cornelussen R, Prinzen F, Delhaas T, Doltra A, Sitges M, Vigmond EJ, Zacur E, Grau V, Rodriguez B, Remme EW, Niederer S, Mortier P, McLeod K, Potse M, Pueyo E, Bueno-Orovio A, Lamata P. The 'Digital Twin' to enable the vision of precision cardiology. Eur Heart J. 2020 Dec 21;41(48):4556-4564. doi: 10.1093/eurheartj/ehaa159.
- BackgroundViceconti M, Henney A, Morley-Fletcher E. In silico clinical trials: how computer simulation will transform the biomedical industry. Int J Clin Trials. 2016;3(2):37-46. Doi: 10.18203/2349-3259.ijct20161408
- Background: PubMed 30635226Heerspink HJL, Greene T, Tighiouart H, Gansevoort RT, Coresh J, Simon AL, Chan TM, Hou FF, Lewis JB, Locatelli F, Praga M, Schena FP, Levey AS, Inker LA; Chronic Kidney Disease Epidemiology Collaboration. Change in albuminuria as a surrogate endpoint for progression of kidney disease: a meta-analysis of treatment effects in randomised clinical trials. Lancet Diabetes Endocrinol. 2019 Feb;7(2):128-139. doi: 10.1016/S2213-8587(18)30314-0. Epub 2019 Jan 8.
- Background: PubMed 31292197Inker LA, Heerspink HJL, Tighiouart H, Levey AS, Coresh J, Gansevoort RT, Simon AL, Ying J, Beck GJ, Wanner C, Floege J, Li PK, Perkovic V, Vonesh EF, Greene T. GFR Slope as a Surrogate End Point for Kidney Disease Progression in Clinical Trials: A Meta-Analysis of Treatment Effects of Randomized Controlled Trials. J Am Soc Nephrol. 2019 Sep;30(9):1735-1745. doi: 10.1681/ASN.2019010007. Epub 2019 Jul 10.
- Background: PubMed 31672251Holtkamp F, Gudmundsdottir H, Maciulaitis R, Benda N, Thomson A, Vetter T. Change in Albuminuria and Estimated GFR as End Points for Clinical Trials in Early Stages of CKD: A Perspective From European Regulators. Am J Kidney Dis. 2020 Jan;75(1):6-8. doi: 10.1053/j.ajkd.2019.07.019. Epub 2019 Oct 28. No abstract available.
- Background: PubMed 28002548Bansal N, Katz R, Robinson-Cohen C, Odden MC, Dalrymple L, Shlipak MG, Sarnak MJ, Siscovick DS, Zelnick L, Psaty BM, Kestenbaum B, Correa A, Afkarian M, Young B, de Boer IH. Absolute Rates of Heart Failure, Coronary Heart Disease, and Stroke in Chronic Kidney Disease: An Analysis of 3 Community-Based Cohort Studies. JAMA Cardiol. 2017 Mar 1;2(3):314-318. doi: 10.1001/jamacardio.2016.4652.
- Background: PubMed 24239921Goff DC Jr, Lloyd-Jones DM, Bennett G, Coady S, D'Agostino RB Sr, Gibbons R, Greenland P, Lackland DT, Levy D, O'Donnell CJ, Robinson JG, Schwartz JS, Shero ST, Smith SC Jr, Sorlie P, Stone NJ, Wilson PWF. 2013 ACC/AHA guideline on the assessment of cardiovascular risk: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2935-2959. doi: 10.1016/j.jacc.2013.11.005. Epub 2013 Nov 12. No abstract available.
- Background: PubMed 42108478Abdullah M, Khalid N, Frishman WH, Aronow WS. Finerenone and Empagliflozin in Type 2 Diabetes. Cardiol Rev. 2026 May 11. doi: 10.1097/CRD.0000000000001308. Online ahead of print.
- Background: PubMed 40470996Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.
- Background: PubMed 42171960Geraci G, Sinatra N, Paterno V, Calabrese V, Cassataro G, Cuttone G, Geraci C, Esposito R, Mancusi C, Pucci G, Zanoli L, Mule G, Polosa R, Ferrara P, Carollo C. Finerenone in Cardiorenal Disease: A Narrative Review of Molecular Mechanisms, Clinical Evidence, and Emerging Therapeutic Roles. Cardiovasc Drugs Ther. 2026 May 22. doi: 10.1007/s10557-026-07890-7. Online ahead of print.
- Individual participant dataSharing planned: No. Because all participants will be virtual
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD - Chronic Kidney Disease and Diabetes Mellitus Type 2, run by Aeterna Medical Solutions SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Occurrence of Incident Heart Failure, Heart Failure Hospitalization, or Cardiovascular Death (time frame: From the beginning of the simulation up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07719621, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.