- A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease — Recruiting • Phase II • Diabetes / Metabolic • NCT06926660.
- Sponsor: Boehringer Ingelheim.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or have certain health conditions cannot take part in this study. The purpose of this study is to find out whether a medicine called vicadrostat, used in combination with another medicine called empagliflozin, works in people with chronic kidney disease. In this study, participants are randomly assigned to one of two…
- : 1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years. 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 3. Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. For men, birth control is not required during the trial. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information. 4. Evidence of Chronic Kidney Disease (CKD) at risk of progression based on two Estimated Glomerular Filtration Rate (eGFR) measurements recorded recently (i.e. within 1 year) and at the time of Visit 1, with each Estimated Glomerular Filtration Rate (eGFR) ≥20 and 5.2 mmol/L at Visit 1. 4. Blood Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >3x Upper limit of normal (ULN) at Visit 1. 5. Known severe hepatic impairment (i.e. Child Pugh class…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.