WithdrawnPhase 2

A Trial to Learn More About How BAY2327949 Works and How Safe it is in Patients Whose Kidneys Are Damaged Due to High Blood Sugar Levels or High Blood Pressures, and With a Further Disease of the Heart or the Blood Vessels.

Stopped: Study withdrawn due to company decision

Austria0Started 2021-05-31

Plain-language summary

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.

Who can participate

Age range45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A clinical diagnosis of chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) ≥ 25 mL/min/1.73 m\^2 but ≤ 60 mL/min/1.73 m\^2 (estimated using the CKD-EPI \[Epidemiology Collaboration\] equation) as assessed during Visit 1, and albuminuria (as measured by urine albumin-to-creatinine ratio \[UACR\]) in the range of ≥ 30 but ≤ 3000 mg/g, based on the first assessment for Visit 1. * CKD with a clinical cause of either T2D or hypertension: -- if T2D is the clinical cause, history of type 2 diabetes mellitus as defined by the American Diabetes Association (on treatment with glucose-lowering medications and/or insulin) for at least 2 years before randomization and on a stable therapy with sodium-glucose transport protein 2 (SGLT2) inhibitor for at least 3 months before randomization; -- if hypertension is the clinical cause, patients must have a history of systolic blood pressure (BP) values ≥ 140 mmHg and/or diastolic BP values ≥ 90 mmHg, and on hypertension medication for at least 5 years before randomization. * Stable treatment with either angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) at the maximal tolerated labelled daily dose and otherwise stable antihypertensive treatment both for at least 3 months before randomization. If taking an SGLT2 inhibitor, the participant must be on stable treatment for at least 3 months before randomization without any planned changes in dosing during the study…

What they're measuring

Change from baseline in urine albumin-to-creatinine ratio (UACR) to the end of treatment (Visit 6)

Timeframe: Baseline and Visit 6 (28 days)

Trial details

NCT IDNCT04661917

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-25