Study on the Safety of the Drug Runcaciguat and How Well it Works When Given at the Highest Dose as Tolerated by Individual Patient Whose Kidneys Are Not Working Properly and Suffering at the Same Time From High Blood Sugar and/or High Blood Pressure and a Disease of the Heart and the Blood Vessels.

Summary

Researchers in this study want to learn more about the safety of the drug runcaciguat and how well it works when given at the highest dose as tolerated by the individual patient whose kidneys are not working properly and suffering at the same time from high blood sugar and/or high blood pressure and a disease of the heart and the blood vessels. Runcaciguat is a new drug under development for the improvement of kidney function. It works by activating proteins that helps to dilate blood vessels, including vessels in the kidneys. This can improve blood flow in kidney and may slow down the progression of kidney disease. This dilative effect can also influence the heart rate and blood pressure. Researchers also wants to find the best dose of the drug during the study. Participants in this study will receive either runcaciguat or placebo tablets every morning for 8 weeks. A placebo looks like the study drug but does not have any active medicine in it. On a weekly basis, the dose of the runcaciguat will be increased step by step. In total, participants will visit the doctors about 10 times, and the observation will last for about 16 weeks. Blood and urine samples will collected from the participants.

Timeline

Start

2020-09-01

Primary completion

2022-03-08

Completion

2022-04-05

Outcome

Met primary endpoint

paper In the PPS, UACR decreased by -45.2% versus placebo with runcaciguat in patients with CKD without SGLT2i (P < 0.001) PMID 39656628 ↗

Publications

• Gansevoort RT, Wheeler DC, Deben FM, Speeckaert M, Thomas D, Berger M, Klein S, Friedrichs F, Paraschin K, Schmieder RE. The soluble guanylate cyclase activator runcaciguat significantly improves albuminuria in patients with chronic kidney disease: a randomized placebo-controlled clinical trial. Nephrol Dial Transplant. 2025 May 30;40(6):1147-1160. doi: 10.1093/ndt/gfae261.
• Kraehling JR, Benardeau A, Schomber T, Popp L, Vienenkoetter J, Ellinger-Ziegelbauer H, Pavkovic M, Hartmann E, Siudak K, Freyberger A, Hagelschuer I, Mathar I, Hueser J, Hahn MG, Geiss V, Eitner F, Sandner P. The sGC Activator Runcaciguat Has Kidney Protective Effects and Prevents a Decline of Kidney Function in ZSF1 Rats. Int J Mol Sci. 2023 Aug 25;24(17):13226. doi: 10.3390/ijms241713226.

Drugs

Indications