What the trial was testing
The trial enrolled 714 patients with kidney disease. The study was sponsored by Boehringer Ingelheim and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
BI 690517 reduced protein in urine by up to 39% in people with chronic kidney disease.
Lancet (London, England) · 2024 · NCT05182840
These findings — that the 10 mg dose lowered protein spillage in urine, a marker of kidney damage — were published in the Lancet (London, England) and represent the headline result of the study.
Researchers tracked outcomes across 714 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with kidney disease, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
This was an initial testing study and BI 690517 is not yet FDA-approved. The drug showed promise in reducing protein spillage in urine, which can indicate slowing kidney damage. About 1 in 7 people had elevated potassium levels, though most didn't need treatment for it. Ask your kidney doctor about approved medications that protect kidney function, and whether similar trials might be right for you.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open kidney disease trials
Study of the Relaxin Agonist R2R01 in Patients at High Risk for Cardiac Surgery Associated- Acute Kidney Injury
This is a Phase 2, dose-ranging, double-blind, double-dummy, placebo-controlled, randomized study preceded by an open label safety run-in, in patients at high risk for Cardiac Surgery Associated - Acute Kidney Injury (CSA-AKI) following coronary artery bypass graft (CABG), valve surgery, aortic surgery, or a combination of the above, involving cardiopulmonary bypass (CPB). Subjects are eligible for screening if they are scheduled for non-emergent CABG, valve surgery, surgery of the ascending part of the aorta, or a combination of the above, involving CPB, within 4 weeks after screening. In addition, subjects are eligible if AKI risk factors are present (at screening): a. If isolated surgery (CABG, single valve surgery, or of the ascending part of the aorta surgery) is scheduled, at least two AKI risk factors should be present b. If combined surgery is scheduled, at least one AKI risk factor should be present Risk factors for AKI are defined below: • Chronic kidney disease (CKD) stage III • Diabetes mellitus on pharmacological treatment • Confirmed diagnosis of hypertension • Documented history of Chronic Heart Failure with New York Heart Association (NYHA) class III or higher * Left ventricular ejection fraction (LVEF) ≤40% * Peripheral vascular disease defined as one or more of the following: claudication, carotid occlusion or \>50% stenosis, amputation for arterial disease, previous or planned intervention on the abdominal aorta, limb arteries or carotids. * Stroke/transient ischemic attack (TIA) defined as sudden onset of focal or global brain, spinal cord, or retinal vascular damage, resulting in symptoms and signs of acute nervous system defects, which is associated with cerebral circulation disorders * Documented atrial fibrillation (AF) on the ECG performed at the screening visit * Anemia with hemoglobin ≤11 g/dL at any time during the 3-month period before or at the time of screening * Body Mass Index (BMI) ≥ 30 kg/m2 * Age ≥70 years at the time of screening The first dose of Investigational Medicinal Product (IMP: R2R01 or Placebo) will be administered subcutaneously (SC) the day before surgery at 06:00 PM (+/- 30 min); the second dose will be administered SC on the day of surgery between 07:00 and 08:00 AM when the surgery is scheduled for the morning, or between 11:00 AM and 12:00 PM when the surgery is scheduled for the afternoon; subsequent doses will be administered SC every 24 hours (+/- 90 min.) starting 24 hours after the second dose, and will continue to be administered until postoperative Day 5 or discharge, whichever occurs first. The follow-up period extends until postoperative Day 30. The study consists of: A. An Open-Label Safety Run-In Part, followed by B. A Double-Blind, Placebo-Controlled, Randomized Part A. An Open-Label Safety Run-In Part The first 10 subjects will be treated with R2R01 5.0 mg SC to ascertain its safety in this population. The Safety Run-In part will be run at the San Raffaele Hospital in Milan (PI Dr. Landoni). Data collected will include but will not be limited to: (1) detailed hemodynamic parameters; (2) use of vasopressors and/or inotropic agents during surgery and in the postoperative period; (3) incidence, severity, and relationship of adverse events (AEs), including serious adverse events (SAEs); (4) postoperative clinical course; (5) available PK data. A Scientific Review Committee (SRC), consisting of three CSA-AKI experts and at least one medical representative of the Sponsor, will review the data from the 5.0 mg dose cohort (open-label Part), based on the safety and available pharmacokinetic data collected from the 10 enrolled patients through postoperative Day 7 or discharge, whichever occurs first. If the SRC agrees to proceed with the 5.0 mg dose, enrollment will open to the randomized part B of the study. If instead, the SRC determines that the 5.0 mg dose is not appropriate, a new dose (i.e., 2.5 mg) will be selected by the SRC for evaluation in 10 additional subjects enrolledin the open-label safety run-in part. Upon completion of the Open-Label Safety Run-In Part, and once the SRC has determined the appropriate R2R01 dose(s) to be tested, enrollment will open to the Double-Blind, Placebo-Controlled, Randomized Part. B. Double-Blind, Placebo-Controlled, Randomized Part Approximately 430 patients will be randomly assigned in a 1:1:1 manner to receive one of the two doses of R2R01or placebo. At randomization, patients will be stratified by presence of CKD stage III (strata: eGFR 59-30 ml/min/1.73m2 vs. eGFR ≥60 ml/min/1.73m2). The randomized part will be conducted at all investigational sites. AKI will be staged according to KDIGO as follows: Stage 1: increase in SCr ≥0.3 mg/dL or an increase in serum creatinine ≥1.5-fold to 2-fold from baseline. Stage 2: incrincrease in SCr \>2-fold to 3-fold from baseline. Stage 3: increase in SCr \>3-fold or SCr ≥4.0 mg/dl or initiation of renal replacement therapy (RRT)
Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial
: IgA-nephropathy is the most common glomerulonephritis with the unfavorable prognosis in patients with persistent albuminuria. Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist that has demonstrated efficacy in reducing albuminuria in patients with CKD and type 2 diabetes in two major trials, FIGARO-DKD and FIDELIO. This finding supported the approval of finerenone by the U.S. Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD). A subgroup analysis in the pooled FIDELITY trial demonstrated that in patients with CKD stages 1-4 and type 2 diabetes (T2D), the cardio- and nephroprotective effects of finerenone were independent of concomitant therapy with SGLT-2 inhibitors or GLP-1 receptor agonists. Thus, the role of finerenone in slowing CKD progression in T2D can be considered well-established. Given its albuminuria-reducing effects, finerenone is being investigated in multiple trials, including studies on non-diabetic kidney disease and IgA nephropathy, though no published results are available yet. In this trial finerenone will be used as a nephroprotective agent above standard treatment in terms of assessing adverse events and potential efficacy.