Do you suffer from Chronic Kidney Disease?
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 inhibitors 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 groups. Participants have an equal chance of being assigned to either group. In one group, participants take the 2 study medicines, vicadrostat and empagliflozin, every day for 3 months. In the other group, participants take placebo and empagliflozin for the first 1.5 months, and then they take vicadrostat and empagliflozin together for the next 1.5 months. The study medicines are taken orally as tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine.
Participants are in the study for about 4 months. During this time, they visit the study site multiple times. Doctors regularly test kidney function by measuring specific proteins in the blood and urine.
The results are compared between the two groups to see whether there are differences between starting the study medicines at the same time or one after the other. The doctors also regularly check participants’ health and take note of any unwanted effects.
Would you like to take part in kidney disease research?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your condition to monitor the safety and effectiveness of the care you’ll receive. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are at least 18 years old.
- Provide signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Are male or female.
- Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council on Harmonization (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.
- Show 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 <60 mL/min/1.73m2, irrespective of urine albumin creatinine ratio (UACR). The first of these measurements will be In Approval assessed from historical local laboratory results, and the second will be determined from serum creatinine analyzed by the central laboratory at Visit 1.
- Have received treatment with a clinically appropriate, stable dose of either Angiotensin-converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) (but not both together) for ≥4 weeks before Visit 1, with no planned changes of the therapy for the duration of the trial
You may not qualify to participate in this study if you:
- Have received treatment with an SGLT2i within 4 weeks before Visit 2. Treatment with a sodium glucose co transporter 2 inhibitor (SGLT2i) should not be interrupted with the intention of enrolment into the trial.
- Have received treatment with an mineralocorticoid receptor antagonist (MRA), aldosterone synthase inhibitor (ASi), or potassium-sparing diuretic(s) within 14 days prior to Visit 1, or requiring such treatment before randomization, or planned during the trial, based on the judgment of the investigator. Treatment with an MRA or ASi should not be interrupted with the intention of enrolment into the trial.
- Have blood potassium of >5.2 mmol/L at Visit 1.
- Have blood Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >3x Upper limit of normal (ULN) at Visit 1.
- Have any known severe hepatic impairment (i.e. Child Pugh class C cirrhosis).
- Are on dialysis, functioning kidney transplant, or scheduled for transplant.
- Have been treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days.
- Are currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone)
There are other eligibility requirements that the study doctor will review. Only the study doctor can determine whether you are eligible to participate in the study or not.
