Clareo Health | A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus
A Study to Learn How Safe the Study Drug Finerenone is and How Well it Works in Indian People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 2 Diabetes Mellitus
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participants capable of giving signed informed consent signed before any study-specific procedure and willing to comply with the study-related procedures.
Diagnosis of chronic kidney disease (CKD) associated with type 2 diabetes (T2D).
Participants who are drug naïve for finerenone or patients who have been initiated on finerenone therapy within 4 weeks before signing the informed consent.
Participants with serum potassium level ≤ 4.8 mmol/L at the time of Screening. If serum potassium level \> 4.8 to 5.0 mmol/L, participants may be enrolled in the study, but additional potassium samples may be required; the potassium level needs to be confirmed during Screening. Participants with potassium level \> 5.0 mmol/L are not allowed. The sample for potassium assessment for confirming eligibility shall be available before initiation of treatment with finerenone.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
You may not be if
Contraindications according to the local marketing authorization:
1. Participants with eGFR \< 25 mL/min/1.73 m\^2 (calculated based on the CKD-EPI equation, using 2009 formula). eGFR can be reassessed once within 48 hours.
2. Participants with severe hepatic impairment (Child-Pugh C).
3. Participants with known hypersensitivity to the study treatment (active substance or excipients).
4. Participants with Type 1 Diabetes.
5. Participants taking concomitant medications that are strong CYP3A4 inhibitors.
6. Participants with Addison's disease.
Glycated hemoglobin \> 12% (17.5 mmol/L) at the Screening visit.
Participants treated with another mineralocorticoid receptor antagonist (MRA), a renin inhibitor, potassium supplements, a potassium sparing diuretic, a potassium binder agent, or angiotensin receptor neprilysin inhibitor (ARNI) within 8 weeks prior to the Screening visit and during finerenone treatment.
Participation in another interventional clinical trial within 30 days prior to the Screening visit and during finerenone treatment.
Female participants who are pregnant or breast-feeding or plan to become pregnant or to breastfeed during the course of the study.
Participants known for lack of compliance with clinic visits or prescribed medication.
