In people with type 2 diabetes (T2D), the body makes insulin, but cannot use it well. This results in high blood sugar levels causing damage to the blood vessels inside the kidneys. High blood pressure is a common condition that can cause damage to the blood vessels and heart if it is untreated. High blood pressure is also known as hypertension. Patients with type 2 diabetes (T2D) or high blood pressure are at a higher risk of having chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. Over time, the function of the kidney declines more, and this can lead to the requirement for dialysis or kidney transplantation. Most people with CKD are also at risk of heart conditions, such as heart attack or stroke. In this trial, the researchers want to learn if BAY2327949 reduces the amount of protein in the participants' urine. Protein in the urine is one of the signs of CKD. The researchers will compare the effects of BAY2327949 to a placebo. A placebo looks like the study drug but does not have any medicine in it. BAY2327949 is assumed to increase the blood flow through the kidneys, which may slow down the worsening of the disease. The researchers will use a placebo to learn if the changes seen in the participants are due to BAY2327949 or if the results could be due to chance. This trial will include about 120 men and women over the age of 45 who have CKD. The participants will have T2D or high blood pressure, and a further disease of the heart or blood vessels. During the trial, the participants will take either BAY2327949 or a placebo once a day for 28 days. The participants will visit their trial site about 9 times during the trial, and need to provide urine samples to check the participants' CKD symptoms. At the visits, the doctors will ask them if they have any health problems. They will also take blood samples to perform laboratory assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
60 mg of BAY2327949 (2 tablets of 30 mg, orally) once daily for 28 days.
Matching placebo orally once daily for 28 days.
Medizinische Universität Graz
Graz, Styria, Austria
Konventhospital Barmherzige Brüder Linz
Linz, Upper Austria, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Vorarlberg, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
Zentrum f. klinische Studien Dr. Hanusch GmbH
Vienna, Austria
Change from baseline in urine albumin-to-creatinine ratio (UACR) to the end of treatment (Visit 6)
Time frame: Baseline and Visit 6 (28 days)
Frequency of treatment-emergent adverse events (TEAEs)
Time frame: From the first treatment with the study intervention until 7 days after the last dose, up to 5 weeks
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Universitätsklinikum AKH Wien
Vienna, Austria
Klinik Hietzing
Vienna, Austria
Aarhus Universitetshospital, Skejby
Aarhus N, Denmark
Sydvestjysk Sygehus Esbjerg
Esbjerg, Denmark
Regionshospitalet Herning
Herning, Denmark
...and 26 more locations