NCT06531824ClinicalTrials.gov

EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)

A Multicenter, International, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease

RekrutiertNimmt laut Registereintrag derzeit Teilnehmende auf.

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Kurz gefasst

Phase 311.000 Teilnehmende gesucht557 Studienzentren20 Länder

Kategorien

Nephrologie und Urologie53%Herz-Kreislauf41%Endokrin und metabolisch4%Geburtshilfe und Gynäkologie2%

In 1 Register registriert

ClinicalTrials.govNCT06531824Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vorgestern

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2024-08-01; recorded start 2024-08-30
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 1218 other studies in this databaseCounted from the lead sponsor named in the record (Boehringer Ingelheim)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
Multi-centre8/8
Multi-centre: 480 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEGA

A very large study, international in scope: 11,000 participants (target), run at 557 sites, across 20 countries.

How this score is built

Enrolment38/40
11,000 participants (target)
Site count25/25
480 sites
Country count15/15
20 countries
Planned duration9/10
Planned over about 49 months
Sponsor scale10/10
Boehringer Ingelheim has led 1,211 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

This study is open to adults with chronic kidney disease at risk of progression. People with and without type 2 diabetes can take part in this study. The study is open to people who take other medicines called angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). People who already take empagliflozin or any other sodium-glucose cotransporter-2 inhibitor (SGLT2i) can also join. The study is also open to people who currently do not take any of these treatments. The purpose of this study is to find out whether a medicine called BI 690517 helps people with chronic kidney disease when taken in combination with a study medicine called empagliflozin. Worsening of kidney function increases the risk for kidney failure, cardiovascular disease, and heart failure hospitalisation. After a run-in period, during which participants are confirmed to be receiving clinically appropriate renin-angiotensin system blockade and are established on empagliflozin, they are randomly assigned (by chance) to 1 of 2 groups. One group receives BI 690517 tablets, and the other group receives placebo tablets. Placebo tablets look like BI 690517 but do not contain any medicine. Participants take 1 study tablet once a day, in addition to empagliflozin, for the duration of the study. The doctors document when participants experience worsening of their kidney disease, go to hospital due to heart failure, or die of cardiovascular problems during the study. The time to these events is compared between the 2 treatment groups to see whether the treatment works. The study continues until the required number of events have occurred which is about 3 to 4 years. During this time, participants visit the study site about 5 times within the first 6 months. Then they visit the study site every 6 months. At the visits, doctors regularly check participants' health, take blood and urine samples, measure blood pressure and weight, check kidney function, and take note of any unwanted effects.

Erkrankungen

Kidney Disease, Chronic

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Key Inclusion Criteria: * Evidence of chronic kidney disease (CKD) at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visit, and requires: 1. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 \<45 mL/min/1.73m² (irrespective of diabetes status); or 2. No self-reported diabetes: CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥150 mg/g (or protein-to-creatinine ratio ≥225 mg/g); or 3. Self-reported diabetes: CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with uACR ≥30 mg/g (or protein-to-creatinine ratio ≥45 mg/g). * Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate. Key Exclusion Criteria: * Blood potassium of \>5.2 mmol/L at screening visit * Blood Alanine Transaminase (ALT) or Aspartate Transaminase (AST) \>3x Upper Limit of Normal (ULN) at Screening visit (only one is required, with ALT preferred) * Known liver cirrhosis * On dialysis, functioning kidney transplant, or scheduled living donor transplant * Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days * Receiving more than one Renin-Angiotensin System (RAS) inhibitor (i.e. on dual therapy with two of an Angiotensin-Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB) or direct renin inhibitor) * Currently treated with an Mineralocorticoid Receptor Antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) * Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	TREATMENT
Verblindung	QUADRUPLE (4)
Teilnahme	11.000 Teilnehmende gesucht

Sponsor und Mitwirkende

Boehringer Ingelheim Sponsor

Studienarme und Interventionen

Part 1: Run-in period (all participants)OTHER
* Participant will receive empagliflozin (called Type E) together with study tablets (called Type F) prior to later randomisation to the main study treatment (Type M). * This run-in period allows empagliflozin to be established and have its effects on kidney function before randomisation, and to make sure participant can tolerate empagliflozin long-term. Participants will not routinely know whether type F treatment is active or inactive so that participants can become familiar with taking main study tablet (Type M) after randomization.
Part 2: Randomized treatment, follow-up period, treatment groupEXPERIMENTAL
Part 2: Follow-up period, placebo groupPLACEBO_COMPARATOR

Interventionen

Arzneimittel BI 690517
BI 690517 (called Type M randomized treatment)
Arzneimittel Empagliflozin
Empagliflozin (called Type E)
Arzneimittel Placebo matching BI 690517
Placebo matching BI 690517

Endpunkte

Primärer Endpunkt
Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.
Kidney disease progression is defined as kidney failure or a sustained decline of ≥40% in estimated Glomerular Filtration Rate (eGFR) from randomization
Zeitrahmen up to 4 years
Sekundärer Endpunkt
Key secondary outcome: Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death
Zeitrahmen up to 4 years
Sekundärer Endpunkt
Key secondary outcome: Time to first event of hospitalization for heart failure or cardiovascular death
Zeitrahmen up to 4 years
Sekundärer Endpunkt
Key secondary outcome: Occurrences of hospitalizations from any cause (first and any subsequent, combined) or death from any cause
Zeitrahmen up to 4 years
Sekundärer Endpunkt
Key secondary outcome: Time to death from any cause
Zeitrahmen up to 4 years
Sekundärer Endpunkt
Key secondary outcome: Annual rate of change in eGFR from 1 month until last scheduled visit (i.e. chronic eGFR slope)
Zeitrahmen up to 4 years
Sekundärer Endpunkt
Time to first event of kidney disease progression or cardiovascular death
Zeitrahmen up to 4 years

Daten

Daten
Startdatum	30. August 2024 (tatsächlich)
Primärer Abschluss	30. August 2028 (geschätzt)
Abschluss	30. August 2028 (geschätzt)
Erstveröffentlichung	1. August 2024 (tatsächlich)
Zuletzt aktualisiert	17. September 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	September 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

557 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Status
Fundacion INTECNUS	Bariloche	Rekrutiert
Terapia Renal Domiciliaria	Buenos Aires	Rekrutiert
Centro de Salud Renal Junin SRL	Buenos Aires	Rekrutiert
Dres. Iribarren & Asoc. Consultario	Buenos Aires	Rekrutiert
Glenny Corp - Centro Medico Saavedra	Buenos Aires	Rekrutiert
CPSIC SRL - Cardiologia Palermo	CABA	Rekrutiert
Sanatorio Pasteur S.A	Catamarca	Rekrutiert
CEMIC	Ciudad Autonoma Buenos Aires	Rekrutiert
CIMEL Chahin - Chahin S.A.	Lanús Este	Rekrutiert
Centro Nefrologico del Mar	Mar del Plata	Rekrutiert
Mains Bleues	Rafaela	Rekrutiert
Sanatorio Parque S.A.	Rosario	Rekrutiert
Hospital Privado de Rosario	Rosario	Rekrutiert
Instituto de Nefrourologia y Nutricion de Salta	Salta	Rekrutiert
Clinica El Castaño	San Juan	Rekrutiert
Centro de Investigaciones Medicas Tucuman	San Miguel de Tucumán	Rekrutiert
Centro Integral de Medicina Respiratoria - CIMER	San Miguel de Tucumán	Rekrutiert
Instituto de Investigaciones Clinicas de Rosario	Santa Fe	Rekrutiert
CEREHA S.A.- Centro de Estudios Renales e Hipertension Arterial	Villa Domínico	Rekrutiert

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Flinders Medical Centre	Bedford Park	South Australia	Rekrutiert
Eastern Health-Box Hill Hospital	Box Hill	Victoria	Rekrutiert
Renal Research, Gosford	Gosford	New South Wales	Rekrutiert
Austin Health	Heidelberg Heights	Victoria	Rekrutiert
St George Hospital	Kogarah	New South Wales	Rekrutiert
Liverpool Hospital	Liverpool	New South Wales	Rekrutiert
The Alfred Hospital	Melbourne	Victoria	Rekrutiert
St Vincent's Hospital Melbourne	Melbourne	Victoria	Rekrutiert
Macquarie University	New South Wales		Rekrutiert
Westmead Hospital	New South Wales		Rekrutiert
Hervey Bay Hospital	Pialba	Queensland	Rekrutiert
Port Macquarie Base Hospital (PMBH)	Port Macquarie	New South Wales	Rekrutiert
Griffith University	Southport	Queensland	Rekrutiert
Sunshine Hospital	St Albans	Victoria	Rekrutiert
Toowoomba Hospital	Toowoomba	Queensland	Rekrutiert

Belgium

Belgium
Einrichtung	Stadt	Status
AZ Sint-Jan Brugge	Bruges	Rekrutiert
Ziekenhuis Oost-Limburg	Genk	Rekrutiert
UZ Brussel	Jette	Rekrutiert
Centre Hospitalier Universitaire de Liège	Liège	Rekrutiert

Brazil

Brazil
Einrichtung	Stadt	Status
Centro de Pesquisa Clínica do Coração	Aracaju	Rekrutiert
Santa Casa de Belo Horizonte	Belo Horizonte	Rekrutiert
Centro de Pesquisa do Hospital Evangelico de Belo Horizonte	Belo Horizonte	Rekrutiert
Universidade Estadual Paulista "Julio De Mesquita Filho"	Botucatu	Rekrutiert
Hospital Universitário São Francisco na Providência de Deus	Bragança Paulista	Rekrutiert
CEG - Centro de Endocrinologia Geloneze	Campinas	Rekrutiert
Instituto Cardiovascular de Linhares Ltda	Centro Linhares	Rekrutiert
PUC Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da PUC-PR	Curitiba	Rekrutiert
Hospital Universitário Walter Cantídio - UFC	Fortaleza	Rekrutiert
Centro de Pesquisas em Diabetes e Doencas Metabolicas	Fortaleza	Rekrutiert
Hospital Ruy Azeredo	Goiânia	Rekrutiert
Clínica CENDI Endocrinologia e Diabetes	Goiânia	Rekrutiert

507 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

17. September 2026
Studienzentrum hinzugefügt
37 sites added (557 total)
520557
2. September 2026
Studienzentrum hinzugefügt
5 sites added (520 total)
515520
21. August 2026
Studienzentrum hinzugefügt
18 sites added (515 total)
497515
10. August 2026
Studienzentrum hinzugefügt
17 sites added (497 total)
480497

https://xmedica.io/trials/ctgov/NCT06531824