A trial to learn how well finerenone works & how safe it is in adult participants with nondiabeticchronic kidney disease
- Conditions
- Chronic kidney disease, stage 3 (moderate),
- Registration Number
- CTRI/2021/11/037917
- Lead Sponsor
- Bayer Pharmaceuticals Private Limited
- Brief Summary
Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD. In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants’ non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old. The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months.
During the trial, the doctors will collect blood and urine samples and check the participants’ health. The participants will also answer questions about how they are feeling and what
adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not
think the adverse events might be related to the trial treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 1500
- A clinical diagnosis of chronic kidney disease and Urine albumin to creatinine ratio of more than equal to 200 but less than equal to 3500 mg/g and estimated glomerular filtration rate more than equal to 25 but less than 90 mL/min/1.73 at screening and Documentation of albuminuria/proteinuria in the participant’s medical records at least 3 months prior to screening.
- Stable and maximum tolerated labeled dose of an Angiotensin-converting enzyme inhibitor or Angiotensin receptor blocker for at least 4 weeks prior to screening Potassium less than equal to 4.8 mmol/L at screening.
- Established diagnosis of Type 1 or 2 Diabetes mellitus or HbA1c more than equal to 6.5 percent.
- Autosomal dominant or autosomal recessive polycystic kidney disease Lupus nephritis or anti-neutrophilic cytoplasmic autoantibody (ANCA) associated vasculitis or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening Symptomatic heart failure with reduced ejection fraction with class 1A indication for Mineralocorticoid receptor antagonists (MRAs).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean rate of change as measured by the total From baseline to month 32 slope of eGFR from baseline to Month-32 From baseline to month 32
- Secondary Outcome Measures
Name Time Method Time to the composite of kidney failure, sustained eGFR decline of more than equal to 57 percent, heart failure Time to the composite of kidney failure or sustained eGFR decline of more than equal to 57 percent. Time to the composite to heart failure hospitalization or CV death Number of participants with Treatment-emergent adverse events
Trial Locations
- Locations (9)
All India Institute of Medical Sciences
🇮🇳North, DELHI, India
Government Medical College Trivandrum
🇮🇳Thiruvananthapuram, KERALA, India
Institute of Post Graduate Medical Education & Research
🇮🇳Kolkata, WEST BENGAL, India
Madras Medical College Chennai
🇮🇳Chennai, TAMIL NADU, India
Mavani Dialysis and Kidney Center.
🇮🇳Ahmadabad, GUJARAT, India
Max Super Speciality Hospital
🇮🇳South, DELHI, India
Noble Hospital Pvt. Ltd
🇮🇳Pune, MAHARASHTRA, India
Osmania General Hospital
🇮🇳Hyderabad, TELANGANA, India
P. D Hinduja Hospital & Medical Research Centre
🇮🇳(Suburban), MAHARASHTRA, India
All India Institute of Medical Sciences🇮🇳North, DELHI, IndiaDr Arunkumar SubbiahPrincipal investigator9968969076gmedaks@gmail.com