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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

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En resumen

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…

Fase 311.000 participantes buscados557 centros20 países

Categorías

Nefrología y urología53%Cardiovascular41%Endocrino y metabólico4%Obstetricia y ginecología2%

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

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

Resumen

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.

Afecciones

  • Kidney Disease, Chronic

Elegibilidad

SexoTodos
Edades18 Years – Sin máximo
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Tipo de estudioDe intervención
FaseFase 3
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción11.000 participantes buscados

Patrocinador y colaboradores

  • Boehringer Ingelheim Patrocinador

Grupos e intervenciones

  • 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

Intervenciones

  • Fármaco BI 690517

    BI 690517 (called Type M randomized treatment)

  • Fármaco Empagliflozin

    Empagliflozin (called Type E)

  • Fármaco Placebo matching BI 690517

    Placebo matching BI 690517

Variables de resultado

  1. Variable de resultado principal

    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

    Plazo up to 4 years

  2. Variable de resultado secundaria

    Key secondary outcome: Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death

    Plazo up to 4 years

  3. Variable de resultado secundaria

    Key secondary outcome: Time to first event of hospitalization for heart failure or cardiovascular death

    Plazo up to 4 years

  4. Variable de resultado secundaria

    Key secondary outcome: Occurrences of hospitalizations from any cause (first and any subsequent, combined) or death from any cause

    Plazo up to 4 years

  5. Variable de resultado secundaria

    Key secondary outcome: Time to death from any cause

    Plazo up to 4 years

  6. Variable de resultado secundaria

    Key secondary outcome: Annual rate of change in eGFR from 1 month until last scheduled visit (i.e. chronic eGFR slope)

    Plazo up to 4 years

  7. Variable de resultado secundaria

    Time to first event of kidney disease progression or cardiovascular death

    Plazo up to 4 years

Fechas

Fecha de inicio30 de agosto de 2024 (real)
Finalización principal30 de agosto de 2028 (estimada)
Finalización30 de agosto de 2028 (estimada)
Primera publicación1 de agosto de 2024 (real)
Última actualización17 de septiembre de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezseptiembre de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

557 centros están en reclutamiento

Argentina

CentroCiudadEstado o regiónEstado
Fundacion INTECNUSBarilocheEn reclutamiento
Terapia Renal DomiciliariaBuenos AiresEn reclutamiento
Centro de Salud Renal Junin SRLBuenos AiresEn reclutamiento
Dres. Iribarren & Asoc. ConsultarioBuenos AiresEn reclutamiento
Glenny Corp - Centro Medico SaavedraBuenos AiresEn reclutamiento
CPSIC SRL - Cardiologia PalermoCABAEn reclutamiento
Sanatorio Pasteur S.ACatamarcaEn reclutamiento
CEMICCiudad Autonoma Buenos AiresEn reclutamiento
CIMEL Chahin - Chahin S.A.Lanús EsteEn reclutamiento
Centro Nefrologico del MarMar del PlataEn reclutamiento
Mains BleuesRafaelaEn reclutamiento
Sanatorio Parque S.A.RosarioEn reclutamiento
Hospital Privado de RosarioRosarioEn reclutamiento
Instituto de Nefrourologia y Nutricion de SaltaSaltaEn reclutamiento
Clinica El CastañoSan JuanEn reclutamiento
Centro de Investigaciones Medicas TucumanSan Miguel de TucumánEn reclutamiento
Centro Integral de Medicina Respiratoria - CIMERSan Miguel de TucumánEn reclutamiento
Instituto de Investigaciones Clinicas de RosarioSanta FeEn reclutamiento
CEREHA S.A.- Centro de Estudios Renales e Hipertension ArterialVilla DomínicoEn reclutamiento

Australia

CentroCiudadEstado o regiónEstado
Flinders Medical CentreBedford ParkSouth AustraliaEn reclutamiento
Eastern Health-Box Hill HospitalBox HillVictoriaEn reclutamiento
Renal Research, GosfordGosfordNew South WalesEn reclutamiento
Austin HealthHeidelberg HeightsVictoriaEn reclutamiento
St George HospitalKogarahNew South WalesEn reclutamiento
Liverpool HospitalLiverpoolNew South WalesEn reclutamiento
The Alfred HospitalMelbourneVictoriaEn reclutamiento
St Vincent's Hospital MelbourneMelbourneVictoriaEn reclutamiento
Macquarie UniversityNew South WalesEn reclutamiento
Westmead HospitalNew South WalesEn reclutamiento
Hervey Bay HospitalPialbaQueenslandEn reclutamiento
Port Macquarie Base Hospital (PMBH)Port MacquarieNew South WalesEn reclutamiento
Griffith UniversitySouthportQueenslandEn reclutamiento
Sunshine HospitalSt AlbansVictoriaEn reclutamiento
Toowoomba HospitalToowoombaQueenslandEn reclutamiento

Belgium

CentroCiudadEstado o regiónEstado
AZ Sint-Jan BruggeBrugesEn reclutamiento
Ziekenhuis Oost-LimburgGenkEn reclutamiento
UZ BrusselJetteEn reclutamiento
Centre Hospitalier Universitaire de LiègeLiègeEn reclutamiento

Brazil

CentroCiudadEstado o regiónEstado
Centro de Pesquisa Clínica do CoraçãoAracajuEn reclutamiento
Santa Casa de Belo HorizonteBelo HorizonteEn reclutamiento
Centro de Pesquisa do Hospital Evangelico de Belo HorizonteBelo HorizonteEn reclutamiento
Universidade Estadual Paulista "Julio De Mesquita Filho"BotucatuEn reclutamiento
Hospital Universitário São Francisco na Providência de DeusBragança PaulistaEn reclutamiento
CEG - Centro de Endocrinologia GelonezeCampinasEn reclutamiento
Instituto Cardiovascular de Linhares LtdaCentro LinharesEn reclutamiento
PUC Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da PUC-PRCuritibaEn reclutamiento
Hospital Universitário Walter Cantídio - UFCFortalezaEn reclutamiento
Centro de Pesquisas em Diabetes e Doencas MetabolicasFortalezaEn reclutamiento
Hospital Ruy AzeredoGoiâniaEn reclutamiento
Clínica CENDI Endocrinologia e DiabetesGoiâniaEn reclutamiento

En el registro figuran 507 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 17 de septiembre de 2026

    Centro añadido

    37 sites added (557 total)

    520557

  2. 2 de septiembre de 2026

    Centro añadido

    5 sites added (520 total)

    515520

  3. 21 de agosto de 2026

    Centro añadido

    18 sites added (515 total)

    497515

  4. 10 de agosto de 2026

    Centro añadido

    17 sites added (497 total)

    480497

Registro: ClinicalTrials.gov · NCT########

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