this international study tests bi 690517 in patients with diabetic kidney disease. the study tests how 3 different doses of bi 690517 are taken up in the body and how well they are tolerated

Conditions: Diabetic Nephropathies

Summary: the primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of bi 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to angiotensin converting enzyme inhibitor \[acei\] or angiotensin-receptor blockers \[arb\]. secondary objective is to evaluate the change from baseline in urine albumin-to-creatinine ratio \[uacr\].


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the trial. * male or postmenopausal (last menstruation ≥ 2 years ago) patients, or female patients who are sterilized by either hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy. male patients with partners of child-bearing potential must be willing to use condoms from the time of the first intake of study drug until follow-up. * egfr (chronic kidney disease epidemiology collaboration \[ckd-epi\] formula) ≥ 20 and \< 75 ml/min/1.73 m2 at visit 1 measured by the central laboratory and no planned start of renal replacement therapy during the trial. * uacr ≥ 200 and \<3500 mg/g in spot urine (midstream urine sample) at visit 1 measured by the central laboratory. * treatment with either acei or arb, stable dose since ≥ 4 weeks before visit 1 with no planned change of the therapy. * patients with type 1 or type 2 diabetes mellitus, diagnosed before informed consent and treated with insulin, glucagon-like peptide (glp) 1 agonists and/or oral antidiabetic medication. treatment should have been unchanged (investigator's judgment) within 4 weeks before visit 1 and until randomisation. * glycated haemoglobin (hba1c) \< 10.0% at visit 1 measured by the central laboratory. * seated sbp ≥ 110 and ≤ 180 mmhg and dbp ≥ 70 and ≤ 110 mmhg at visit 1 * age at screening ≥ 18 years for male and permanently sterilized female patients and ≥ 45 years for postmenopausal female patients. * body mass index (bmi) ≥ 18.5 and \< 45 kg/m2. exclusion criteria: * treatment with with sglt2 inhibitors and/or inhibitors of aldosterone mediated effects like mineralocorticoid receptor antagonists at visit 1 and thereafter. * intake of potassium sparing diuretics like amiloride or potassium supplements during the study (this period starts at visit 1). * at visit 1 cortisol peak level 30 minutes (± 5 min) after iv injection of adrenocorticotropic hormone (acth) is an increase by less than 200 nmol/l compared to pre-acth injection. * dual or triple blockade of the renin angiotensin system (ras) (e.g. acei + arb; acei + renin inhibitor; or arb + renin inhibitor; or acei + arb + renin inhibitor) 12 weeks before visit 1 and for the duration of study. * history of non-diabetic renal disease according to investigator's opinion and/or renal transplant recipients. * hyperkalaemia (k+ \> 5.0 mmol/l) at visit 1 and until start of treatment measured by any local or central lab. * clinical signs of acute or chronic urinary tract infection 14 days before randomization (based on investigator's judgement). * acute febrile diseases 14 days before randomisation (based on investigator´s judgement). * heart failure, patients with nyha iii / iv. * surgery or trauma with significant blood loss or blood donation within 12 weeks prior to first administration of study medication (based on investigator´s judgement) or planned surgeries during the trial e.g. hip replacement (based on investigator's judgement). * any other medical condition that in the investigator's opinion poses a safety risk for the patient or may interfere with the study objectives. * any laboratory value more than 3 times above upper limit normal (uln) at screening (visit 1) or any other laboratory value outside the reference range and clinically relevant in the investigator's judgment. * medical history of cancer or treatment for cancer in the last two years prior to visit 1 (except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of uterine cervix, and prostatic cancer of low grade \[t1 or t2\] is exempted). * previous enrolment in this trial. * currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s). * chronic alcohol or drug abuse or any condition that, in the investigator's opinion, makes them an unreliable study patient or unlikely to complete the trial. * women of childbearing potential * further exclusion criteria apply