diabetic kidney disease diabetic nephropathy
Conditions
Interventions
All patients will start on 1 mg TID BI 685509 or matching placebo. If the
medication is tolerated, up-titration to 2 mg TID BI 685509 or matching placebo
will occur after 2 weeks for patients in dos
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial. 2. Male or female patients aged >= 18 years at time of consent. 3. eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) >= 20 and = 20 mL/min/1.73 m2 after Visit 1 up to the start of Visit 3, measured by central or any local laboratory analysis. 4. UACR >= 200 and = 4 weeks before Visit 1 with no planned change of the therapy during the trial. 6. If the patient is taking any of the following medications they should be on a stable dose at least 4 weeks prior to visit 1 until start of treatment, with no planned change of the therapy during the trial: anti hypertensives, NSAIDs, endothelin receptor antagonists, systemic steroids or SGLT2 inhibitors. 7. Patients with stable type 1 or type 2 diabetes mellitus, diagnosed before informed consent. Treatment (including SGLT2 inhibitor and/or GLP1 receptor agonist) should have been unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks before Visit 1 and until start of trial treatment. 8. Glycated Haemoglobin (HbA1c) = 110 and = 65 and = 18.5 and
Exclusion criteria
Exclusion criteria: 1. Treatment with Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either ACEi or ARB), phosphodiesterase inhibitors, nitrates, sGC-stimulators/activators (other than trial treatment) or any other restricted medication (including OATP1B1/3 inhibitors, UGT inhibitors/inducers) as provided in the Investigator Site File (ISF) within 4 weeks prior to visit 1 and throughout screening and baseline run-in. Patients who must or wish to continue the intake of restricted medications (see section 4.2.2.1) or any drug considered likely to interfere with the safe conduct of the trial are also excluded. 2. Any clinically relevant laboratory value from screening until start of trial treatment, which in the investigator's judgement puts the patient at additional risk. 3. Biopsy or otherwise confirmed non-diabetic chronic kidney disease, or non-diabetic chronic kidney disease in the opinion of investigator, e.g., Autosomal Dominant Polycystic Kidney Disease (ADPKD), uncontrolled lupus nephritis. The presence of a hypertensive etiology does not need to be excluded unless it is evident this is the only cause for the CKD. 4. Any immunosuppression therapy or immunotherapy in the last 3 months prior to visit 1 and throughout screening and baseline run-in (except prednisolone 450 ms in men or > 470 ms in women at any time from screening (Visit 1) until start of treatment. 18. A family history of long QT syndrome. 19. Concomitant use of therapies with a known risk of Torsade de Pointes at screening (Visit 1) and throughout screening and baseline run-in or planned initiation of such therapies during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment. - Proportion of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment. - Proportion of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment. | — |
Countries
Netherlands
Outcome results
None listed