A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease
Summary
This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study. The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin. In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine. In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine. Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.
Timeline
- Start
- 2022-01-11
- Primary completion
- 2023-06-19
- Completion
- 2023-07-10
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry p = 0.0007; Mean Difference (Net) -0.469 (95% CI -0.737 to -0.201); MMRM reads as mixed primary results NCT05182840 ↗
registry p = 0.0867; Mean Difference (Net) -0.227 (95% CI -0.488 to 0.033); MMRM reads as mixed primary results NCT05182840 ↗
release “Phase II results demonstrated significant albuminuria reductions by up to 39.5% vs. placebo when BI 690517” reads as met primary endpoint prnewswire.com ↗
Publications
- Cherney DZI, Rossing P, Canziani ME, Caramori ML, Correa-Rotter R, Cronin L, Hugo C, Ji B, Meyerhoff J, Nangaku M, Silva A, Urbach D, Shah SV, de Zeeuw D, Tuttle KR. Effects of Vicadrostat/Empagliflozin in People With Chronic Kidney Disease: Metabolic Subgroup Analyses. Diabetes Obes Metab. 2026 Jul;28(7):6324-6333. doi: 10.1111/dom.70836. Epub 2026 May 5.
- Gashaw IA, Tuttle KR, Monroy Kuhn M, Pleiner S, Delic D, Cronin L, Shah SV, Rossing P. Pharmacodynamics of vicadrostat for aldosterone synthase inhibition in patients with CKD. Eur J Endocrinol. 2026 Jan 6;194(1):46-57. doi: 10.1093/ejendo/lvaf265.
- Tuttle KR, Hauske SJ, Canziani ME, Caramori ML, Cherney D, Cronin L, Heerspink HJL, Hugo C, Nangaku M, Rotter RC, Silva A, Shah SV, Sun Z, Urbach D, de Zeeuw D, Rossing P; ASi in CKD group. Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial. Lancet. 2024 Jan 27;403(10424):379-390. doi: 10.1016/S0140-6736(23)02408-X. Epub 2023 Dec 15.
- Tuttle KR, Rossing P, Hauske SJ, Cronin L, Hussain J, de Zeeuw D, Heerspink HJL. Methods Article for a Study Protocol: Study Design and Baseline Characteristics for Aldosterone Synthase Inhibition in Chronic Kidney Disease. Am J Nephrol. 2024;55(2):262-272. doi: 10.1159/000534808. Epub 2023 Oct 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Vicadrostat | Small molecule | 3 mg | Oral |
| Subject | Vicadrostat | Small molecule | 10 mg | Oral |
| Subject | Vicadrostat | Small molecule | 20 mg | Oral |