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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
243
Titrated dose of active dose 1, dose 2, dose 3, dose 4 of runcaciguat will be administered orally once a day.
Sham-titrated dose of matching placebo will be administered orally once a day.
Medizinische Universität Innsbruck
Innsbruck, Austria
Klinik Landstraße - Krankenhaus Rudolfstiftung
Vienna, Austria
Zentrum f. klinische Studien Dr. Hanusch GmbH
Vienna, Austria
Universitätsklinikum AKH Wien
Vienna, Austria
Klinik Hietzing
Vienna, Austria
OL Vrouwziekenhuis - Campus Aalst
Mean change in urinary albumin-to-creatinine ratio (UACR) from baseline to the average of multiple time points during treatment
Time frame: From baseline up to day 57 (± 3)
Number of subjects with treatment emergent adverse event (TEAE)
Time frame: From first treatment administration up to end of follow up (Day 87±7)
Number of subjects with early discontinuations
Time frame: From first treatment administration up to end of treatment (Day 57±3)
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Med Centre Diamedical 2013
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