At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BI 690517 (drug), Placebo matching BI 690517 (drug), Empagliflozin (drug)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- BI 690517 — drug: BI 690517 (called Type M randomized treatment) · Placebo matching BI 690517 — drug: Placebo matching BI 690517 · Empagliflozin — drug: Empagliflozin (called Type E)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 11,000
- Started
- 2024-08-30
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for kidney disease, chronic
- • Phase3 - 11,000 participants
- • This study is open to adults with chronic kidney disease at risk of progression
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with kidney disease, chronic
Where?
- • Antrim - Antrim Area Hospital
- • Basildon - Basildon Hospital
- • Belfast - Ulster Hospital
- • Belfast - Beltfast City Hospital
- • +67 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR ≥20 \<45 mL/min/1.73m² (irrespective of diabetes...
- ✓No self-reported diabetes: CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥150...
- ✓Self-reported diabetes: CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with uACR ≥30 mg/g (or protein-to-creatinine ratio ≥45...
- ✓Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that...
Who cannot take part
- ✗Blood potassium of \>5.2 mmol/L at screening visit
- ✗Blood Alanine Transaminase (liver enzymes) or Aspartate Transaminase (liver enzymes) \>3x Upper Limit of Normal (ULN) at Screening visit...
- ✗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...
See the full criteria
Where Is This Study? (71 UK sites)
Antrim Area Hospital
Antrim BT41 2RL, United Kingdom
Basildon Hospital
Basildon SS16 5NL, United Kingdom
Ulster Hospital
Belfast BT16 1RH, United Kingdom
Beltfast City Hospital
Belfast BT9 7AB, United Kingdom
Fernley Medical Centre
Birmingham B11 4AN, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham B15 2WB, United Kingdom
Burbury Medical Centre
Birmingham B19 1TT, United Kingdom
West Heath Surgery
Birmingham B31 3HB, United Kingdom
Ridgacre House Surgery
Birmingham B32 2TJ, United Kingdom
Oakenhurst Medical Practice
Blackburn BB2 1AX, United Kingdom
Royal County Sussex Hospital
Brighton BN2 1ES, United Kingdom
Southmead Hospital
Bristol BS10 5NB, United Kingdom
Pioneer Ridingleaze
Bristol BS11 0QE, United Kingdom
Lawrence Hill Health Centre
Bristol BS2 0AN, United Kingdom
Coniston Medical Practice
Bristol BS34 5TF, United Kingdom
West Suffolk Hospital
Bury St Edmunds IP33 2QZ, United Kingdom
Broomfield Hospital
Chelmsford CM1 7ET, United Kingdom
Main Email: mse.lehprimarycareresearch@nhs.net
mse.lehprimarycareresearch@nhs.net01245 516339Hathaway Medical Centre
Chippenham SN14 6GT, United Kingdom
Clevedon Medical Centre
Clevedon BS21 6DG, United Kingdom
Queen Alexandra Hospital
Cosham PO6 3LY, United Kingdom
Daisy Hill Hospital
County Down BT35 8DR, United Kingdom
University Hospital Coventry
Coventry CV2 2DX, United Kingdom
The Village Surgery
Cramlington NE23 6US, United Kingdom
Orchard Court Surgery
Darlington DL3 6HZ, United Kingdom
Darent Valley Hospital
Dartford DA2 8DA, United Kingdom
Dorset County Hospital
Dorchester DT1 2JY, United Kingdom
Anthony Homer. Research Governance Manager
Research@dchft.nhs.uk01305 253 127Russells Hall Hospital
Dudley DY1 2HQ, United Kingdom
University Health Centre
Durham DH1 3JX, United Kingdom
Highland Clinical Research Facility
Fulwood PR2 9HT, United Kingdom
Woodlands Family Practice
Gillingham ME7 2BU, United Kingdom
Gloucestershire Royal Hospital
Gloucester GL1 3NN, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467James Paget University Hospital
Great Yarmouth NR31 6LA, United Kingdom
The Garth Surgery
Guisborough TS14 7DJ, United Kingdom
Hereford County Hospital
Hereford HR1 2BN, United Kingdom
Ipswich Hospital (UK)
Ipswich IP4 5PD, United Kingdom
The Queen Elizabeth Hospital
Kings Lynn PE30 4ET, United Kingdom
Pinfold Surgery
Leeds LS26 9AA, United Kingdom
Ryeland Surgery
Leominster HR6 8HD, United Kingdom
St Luke's Hospital
Little Horton Lane BD5 0NA, United Kingdom
Aintree University Hospital
Liverpool L9 7AL, United Kingdom
North Middlesex University Hospital
London N18 1QX, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
St George's Hospital
London SW17 0QT, United Kingdom
Hammersmith Hospital
London W12 0HS, United Kingdom
Richford Gate Medical Practice
London W6 7HY, United Kingdom
Altnagelvin Area Hospital
Londonderry BT47 6SB, United Kingdom
Arrowe Park Hospital
Metropolitan Borough of Wirral CH49 5PE, United Kingdom
Linthorpe Surgery
Middlesbrough TS5 6HA, United Kingdom
Norfolk and Norwich University Hospital
Norfolk NR4 7UY, United Kingdom
Northampton General Hospital
Northampton NN1 5BD, United Kingdom
Michelle Spinks, Head of Research
ngh-tr.research.unit@nhs.net01604 545941Banbury Cross Health Centre
Oxford OX16 9AD, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
St Bartholomews & Hollow Way Med Centre
Oxford OX4 1XB, United Kingdom
Pickering Medical Practice
Pickering YO18 8BL, United Kingdom
Lilliput Surgery
Poole BH14 8EE, United Kingdom
Royal Berkshire Hospital
Reading RG1 5AN, United Kingdom
Leslie Frederick-Mokogwu
researchanddevelopment@royalberkshire.nhs.uk0118 322 7449Alexandra Hospital
Redditch B98 7UB, United Kingdom
Salford Royal Hospital
Salford M6 8HD, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury SY3 8XQ, United Kingdom
St Helens Hospital
St Helens WA9 3DA, United Kingdom
Lister Hospital
Stevenage SG1 4AB, United Kingdom
Rishma Bhatti, Head of Research (Mount Vernon Cancer Centre)
mvccresearch.enh-tr@nhs.net0203 826 2068 / 2069Great Western Hospital
Swindon SN3 6BB, United Kingdom
Royal Cornwall Hospital
Truro TR1 3LJ, United Kingdom
Church Street Practice
Wantage OX12 9BN, United Kingdom
Southend University Hospital
Westcliff-on-Sea SS0 0RY, United Kingdom
168 Parklands Medical Centre
Weston-super-Mare BS24 7PR, United Kingdom
Estuary View Medical Centre
Whitstable CT5 3SE, United Kingdom
Windrush Medical Practice
Witney OX28 6JS, United Kingdom
Eynsham Medical Group
Witney OX29 4QB, United Kingdom
Woodthorpe Surgery
York YO24 2RQ, United Kingdom