3
Clinical Trials associated with EnuvaptanA Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Efficacy and Safety of BAY 2327949 in Patients With Chronic Kidney Disease (eGFR Range From 25 to 60 mL/Min/1.73 m²) Due to Type 2 Diabetes or Hypertension and at Least One Cardiovascular Comorbidity
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.
A Randomized, 2-way Crossover, Placebo-controlled, Double-blind Study to Evaluate Effects of Single Oral Doses of BAY 2327949 on Renal Perfusion in Participants With Moderate Chronic Kidney Disease
Researchers in this study want to learn more about the effect of a new drug called BAY2327949 on the blood flow through kidneys in adult participants with moderate long lasting kidney disease. It is thought that, in long lasting kidney disease, blood flow through the kidney tissue is changed, and that some parts of the kidney may receive less oxygen and nutrients because of this. BAY2327949 is a new drug under development with a goal to modify how much blood is flowing through kidneys. It works by binding to and blocking proteins that can regulate blood flow through the kidneys.
Participants in this study will receive 3 tablets of BAY2327949 once and 3 tablets of Placebo once (a placebo looks like a drug but does not have any medicine in it). Both BAY2327949 and Placebo will be taken orally. And after taking each of them, participants will undergo a Magnetic Resonance Imaging (MRI) scanning for 60 to 90 minutes to assess the blood flow to kidneys. MRI is an examination of parts of the body (in this case the kidney) which provides images of these regions. Blood samples will be collected from the participants to check the general health and look at how the study drug is working in the body and how the body affects the study drug. Participants will visit the hospital or clinic about 4 times in total, and the observation for each participant will not more than 56 days.
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of a Single Oral Dose of BAY2327949 Given as Immediate Release Tablet in Male and Female Participants in a Multi-center, Non-randomized, Non-controlled, Non-blinded Study With Group Stratification in Participants With Renal Impairment and Healthy Participants Matched for Age, Gender, and Weight
BAY2327949 is currently under clinical development for chronic kidney disease. The goal of this study is to learn more about how the body absorbs, distributes and excretes the study drug when taken once per mouth as 30mg tablet. An additional important goal of this study is to gain more information on how well the study drug is tolerated and its effect on the human body functions. The study will enroll healthy participants or patients with mild, moderate or severe reduced kidney functions matched for age, weight and gender. The results of this study will help researchers to select the best dosing of the study drug for future studies in patients.
100 Clinical Results associated with Enuvaptan
100 Translational Medicine associated with Enuvaptan
100 Patents (Medical) associated with Enuvaptan
100 Deals associated with Enuvaptan