A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes
- Conditions
- Chronic Kidney DiseaseType 1 Diabetes Mellitus
- Registration Number
- NCT05901831
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria:<br><br> - Participant must be =18 years of age (or the legal age of consent according to local<br> legislation) at the time of signing the informed consent.<br><br> - Participants with Type 1 diabetes (T1D), i.e. T1D continuously treated with insulin,<br> started within one year from diagnosis.<br><br> - If the onset was after age 35, documentation of the presence of one or more of<br> the following:<br><br> - Circulating T1D-associated autoantibodies<br><br> - Hospitalization for diabetic ketoacidosis<br><br> - Plasma C-peptide below the limit of detection with standard assay (with<br> concurrent blood glucose >100 mg/dl).<br><br> - HbA1c at Screening <10% (central assessment).<br><br> - Note: One reassessment is allowed for HbA1c during the Screening period in case<br> the first measurement is missing/unreadable/invalid.<br><br> - K+ = 4.8 mmol/L at Screening (local assessment)<br><br> - Participants with a clinical diagnosis of CKD and fulfilling both the criteria<br> (central assessment):<br><br> - eGFR =25 and <90 mL/min/1.73 m^2 using CKD-EPI (Chronic Kidney Disease<br> Epidemiology Collaboration) 2009 formula at the Screening visit<br><br> - UACR =200 mg/g (22.6 mg/mmol) to <5000 mg/g (565 mg/mmol) at the Screening<br> visit (geometric mean of the 3 measurements)<br><br> - Participants on a stable (preferably without any change in the dosage for at least 4<br> weeks prior to the Screening visit) ACEI (Angiotensin-converting enzyme inhibitor)<br> or ARB (Angiotensin receptor blocker) treatment.<br><br>Exclusion Criteria:<br><br> - Participant with T2D (Type 2 diabetes).<br><br> - Participant with mean BP (Blood pressure) higher than 160/100 mmHg or mean systolic<br> BP lower than 90 mmHg at the Screening visit<br><br> - Symptomatic heart failure with reduced ejection fraction with class 1A indication<br> for Mineralocorticoid receptor antagonists (MRAs).<br><br> - Participants with current or previous (within 8 weeks prior to the Screening visit)<br> treatment with a SGLT-2/-1 (Sodium-Glucose co-transporter-2/-1) inhibitor or GLP1<br> (Glucagon-like peptide-1) receptor agonist.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Urinary albumin-to-creatinine ratio (UACR)
- Secondary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events (TEAEs), Treatment-emergent serious adverse event (TESAEs);Number of participants with Hyperkalaemia