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Combination treatment for chronic kidney disease with BI 690517 and 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

Phase 3 Interventional Boehringer Ingelheim · NCT06531824

This study is testing if a new combination of medications can help adults with chronic kidney disease feel better and prevent their condition from getting worse.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment11000 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations452 sites (Huntsville, Alabama and 451 other locations)
Trial IDNCT06531824 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of a medication called BI 690517 in combination with empagliflozin on adults with chronic kidney disease (CKD) who are at risk of disease progression. Participants, including those with and without type 2 diabetes, will receive either the active treatment or a placebo for at least six weeks while continuing their current medications, such as ACE inhibitors or ARBs. The aim is to determine if this combination therapy can help improve kidney function and reduce the risk of complications associated with CKD.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic kidney disease at risk of progression, with specific eGFR and urine albumin-to-creatinine ratio criteria.

Not a fit: Patients currently on dialysis, with liver cirrhosis, or those requiring certain contraindicated medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow the progression of chronic kidney disease and reduce the risk of kidney failure and cardiovascular issues.

How similar studies have performed: Other studies have shown promise in using SGLT2 inhibitors for kidney protection, suggesting a potential for success with this combination approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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; or
  2. CKD-EPI eGFR ≥45 \<90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) ≥200 mg/g (or protein-to-creatinine ratio ≥300 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
* 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.

Where this trial is running

Huntsville, Alabama and 451 other locations

+402 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Kidney Disease, Chronic
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.