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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 3مطلوب 11,000 مشارك557 موقعاً20 دولة

الفئات

الكلى والمسالك البولية53%القلب والأوعية الدموية41%الغدد الصمّاء والأيض4%التوليد وأمراض النساء2%

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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.

الحالات

  • Kidney Disease, Chronic

الأهلية

الجنسالجميع
الأعمار18 Years – لا حد أقصى
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 3
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 11,000 مشارك

الجهة الراعية والمتعاونون

  • Boehringer Ingelheim الجهة الراعية

الأذرع والتدخلات

  • 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

التدخلات

  • دواء BI 690517

    BI 690517 (called Type M randomized treatment)

  • دواء Empagliflozin

    Empagliflozin (called Type E)

  • دواء Placebo matching BI 690517

    Placebo matching BI 690517

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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

    الإطار الزمني up to 4 years

  2. مقياس النتيجة الثانوي

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

    الإطار الزمني up to 4 years

  3. مقياس النتيجة الثانوي

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

    الإطار الزمني up to 4 years

  4. مقياس النتيجة الثانوي

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

    الإطار الزمني up to 4 years

  5. مقياس النتيجة الثانوي

    Key secondary outcome: Time to death from any cause

    الإطار الزمني up to 4 years

  6. مقياس النتيجة الثانوي

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

    الإطار الزمني up to 4 years

  7. مقياس النتيجة الثانوي

    Time to first event of kidney disease progression or cardiovascular death

    الإطار الزمني up to 4 years

التواريخ

تاريخ البدء30 أغسطس 2024 (فعلي)
الإتمام الأولي30 أغسطس 2028 (تقديري)
الإتمام30 أغسطس 2028 (تقديري)
أول نشر1 أغسطس 2024 (فعلي)
آخر تحديث17 سبتمبر 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةسبتمبر 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

557 موقعاً قيد التجنيد

Argentina

المنشأةالمدينةالولاية أو المنطقةالحالة
Fundacion INTECNUSBarilocheقيد التجنيد
Terapia Renal DomiciliariaBuenos Airesقيد التجنيد
Centro de Salud Renal Junin SRLBuenos Airesقيد التجنيد
Dres. Iribarren & Asoc. ConsultarioBuenos Airesقيد التجنيد
Glenny Corp - Centro Medico SaavedraBuenos Airesقيد التجنيد
CPSIC SRL - Cardiologia PalermoCABAقيد التجنيد
Sanatorio Pasteur S.ACatamarcaقيد التجنيد
CEMICCiudad Autonoma Buenos Airesقيد التجنيد
CIMEL Chahin - Chahin S.A.Lanús Esteقيد التجنيد
Centro Nefrologico del MarMar del Plataقيد التجنيد
Mains BleuesRafaelaقيد التجنيد
Sanatorio Parque S.A.Rosarioقيد التجنيد
Hospital Privado de RosarioRosarioقيد التجنيد
Instituto de Nefrourologia y Nutricion de SaltaSaltaقيد التجنيد
Clinica El CastañoSan Juanقيد التجنيد
Centro de Investigaciones Medicas TucumanSan Miguel de Tucumánقيد التجنيد
Centro Integral de Medicina Respiratoria - CIMERSan Miguel de Tucumánقيد التجنيد
Instituto de Investigaciones Clinicas de RosarioSanta Feقيد التجنيد
CEREHA S.A.- Centro de Estudios Renales e Hipertension ArterialVilla Domínicoقيد التجنيد

Australia

المنشأةالمدينةالولاية أو المنطقةالحالة
Flinders Medical CentreBedford ParkSouth Australiaقيد التجنيد
Eastern Health-Box Hill HospitalBox HillVictoriaقيد التجنيد
Renal Research, GosfordGosfordNew South Walesقيد التجنيد
Austin HealthHeidelberg HeightsVictoriaقيد التجنيد
St George HospitalKogarahNew South Walesقيد التجنيد
Liverpool HospitalLiverpoolNew South Walesقيد التجنيد
The Alfred HospitalMelbourneVictoriaقيد التجنيد
St Vincent's Hospital MelbourneMelbourneVictoriaقيد التجنيد
Macquarie UniversityNew South Walesقيد التجنيد
Westmead HospitalNew South Walesقيد التجنيد
Hervey Bay HospitalPialbaQueenslandقيد التجنيد
Port Macquarie Base Hospital (PMBH)Port MacquarieNew South Walesقيد التجنيد
Griffith UniversitySouthportQueenslandقيد التجنيد
Sunshine HospitalSt AlbansVictoriaقيد التجنيد
Toowoomba HospitalToowoombaQueenslandقيد التجنيد

Belgium

المنشأةالمدينةالولاية أو المنطقةالحالة
AZ Sint-Jan BruggeBrugesقيد التجنيد
Ziekenhuis Oost-LimburgGenkقيد التجنيد
UZ BrusselJetteقيد التجنيد
Centre Hospitalier Universitaire de LiègeLiègeقيد التجنيد

Brazil

المنشأةالمدينةالولاية أو المنطقةالحالة
Centro de Pesquisa Clínica do CoraçãoAracajuقيد التجنيد
Santa Casa de Belo HorizonteBelo Horizonteقيد التجنيد
Centro de Pesquisa do Hospital Evangelico de Belo HorizonteBelo Horizonteقيد التجنيد
Universidade Estadual Paulista "Julio De Mesquita Filho"Botucatuقيد التجنيد
Hospital Universitário São Francisco na Providência de DeusBragança Paulistaقيد التجنيد
CEG - Centro de Endocrinologia GelonezeCampinasقيد التجنيد
Instituto Cardiovascular de Linhares LtdaCentro Linharesقيد التجنيد
PUC Trials - Núcleo de Pesquisa Clínica da Escola de Medicina da PUC-PRCuritibaقيد التجنيد
Hospital Universitário Walter Cantídio - UFCFortalezaقيد التجنيد
Centro de Pesquisas em Diabetes e Doencas MetabolicasFortalezaقيد التجنيد
Hospital Ruy AzeredoGoiâniaقيد التجنيد
Clínica CENDI Endocrinologia e DiabetesGoiâniaقيد التجنيد

تُدرَج 507 مواقع إضافية في سجل السجل.

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 17 سبتمبر 2026

    أُضيف موقع

    37 sites added (557 total)

    520557

  2. 2 سبتمبر 2026

    أُضيف موقع

    5 sites added (520 total)

    515520

  3. 21 أغسطس 2026

    أُضيف موقع

    18 sites added (515 total)

    497515

  4. 10 أغسطس 2026

    أُضيف موقع

    17 sites added (497 total)

    480497

السجل: ClinicalTrials.gov · NCT########

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