NCT04507061

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.

A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Individually Titrated Oral Doses of Runcaciguat in Subjects With Clinical Diagnosis of Chronic Kidney Disease With Diabetes and/or Hypertension and at Least One Cardiovascular Comorbidity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	runcaciguat	Titrated dose of active dose 1, dose 2, dose 3, dose 4 of runcaciguat will be administered orally once a day.
OTHER	Placebo	Sham-titrated dose of matching placebo will be administered orally once a day.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-03-08
• Completion: 2022-04-05
• First posted: 2020-08-10
• Last updated: 2023-04-04

Locations

71 sites across 13 countries: Austria, Belgium, Bulgaria, Denmark, Finland, Germany, Israel, Italy, Poland, Slovakia, Spain, Sweden, Ukraine