Last updated 5 days ago
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
416 patients around the world
Available in Brazil, Argentina, Belgium
Boehringer Ingelheim
7Research sites
416Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years.Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.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.Evidence of Chronic Kidney Disease (CKD) at risk of progression based on two Estimated Glomerular Filtration Rate (eGFR) measurements recorded recently 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 assessed from historical local laboratory results, and the second will be determined from serum creatinine analysed by the central laboratory at Visit 1.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.
- 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.Treatment with an mineralocorticoid receptor antagonist (MRA), aldosterone synthase inhibitor (ASi), or potassium-sparing diuretic(s) within 14 days prior to Visit 1. Requiring such treatment before randomisation, 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.Blood potassium of >5.2 mmol/L at Visit 1.Blood Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >3x Upper limit of normal (ULN) at Visit 1.Known severe hepatic impairment (i.e. Child Pugh class C cirrhosis).On dialysis, functioning kidney transplant, or scheduled for transplant.Treated with new immunosuppression therapy for new or relapse/flare of pre-existing kidney disease within the last 60 days.Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone).Further exclusion criteria apply.
Sites
Instituto de Diagnóstico e Investigaciones Metabólicas - IDIM - sede centro - CABA
Fundación Sanatorio Güemes - CABA, Buenos Aires
CEDIC Centro de Investigación Clínica - CABA, Buenos Aires
Instituto Medico Catamarca "IMEC"
Centro Especialidades Médicas SRL (CEMEDIC)
Mautalen - Salud e Investigación - CABA
Fundação Faculdade Regional de Medicina de São José do Rio Preto
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Chronic kidney disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06926660
