Trial to evaluate drug finerenone in Indian patients with Kidney disease associated to diabetes.

Phase 4

• Conditions: Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

• Registration Number: CTRI/2023/01/049213
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Participants capable of giving signed informed consent signed before any study specific procedure and willing to comply with the study-related procedures. If a participant is incapable of giving signed informed consent, legally authorized representative (LAR) of participant can also sign the ICF.

2) Diagnosis of CKD associated with T2D.

3) Participants who are drug naïve for finerenone or patients who have been initiated on finerenone therapy within 4 weeks before signing the informed consent.

4) 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.

5) Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

a) Women of childbearing potential (WOCBP) can only be included in the study if a urine pregnancy test is negative at the Screening visit and if they agree to use adequate contraception during the study and until 8 weeks after the last dose of finerenone. Adequate contraception is defined as any combination of at least two effective methods of birth control, of which at least one is a physical barrier (e.g., condoms with hormonal contraception or implants or combined oral contraceptives, certain intrauterine devices).

b) Postmenopausal females (no menses for 12 months without an alternative medical cause; see Appendix 4) are not required to use contraception. A high follicle-stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with more than one FSH measurement is required.

c) Females on HRT and whose menopausal status is in doubt will be required to use one of the non-estrogen hormonal highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.

d) Females of nonchildbearing potential (documented hysterectomy, documented bilateral salpingectomy, documented bilateral oophorectomy) are not required to use contraception.

e) For females with permanent infertility due to an alternate medical cause other than the above (e.g., Mullerian agenesis, androgen insensitivity), investigator discretion should be applied to determining study entry.

Exclusion Criteria

1) Contraindications according to the local marketing authorization:

a) Participants with eGFR < 25 mL/min/1.73m2 (calculated based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation, using 2009 formula). eGFR can be reassessed once within 48 hours.

b) Participants with severe hepatic impairment (Child-Pugh C).

c) Participants with known hypersensitivity to the study treatment (active substance or excipients).

d) Participants with Type 1 Diabetes

e) Participants taking concomitant medications that are strong CYP3A4 inhibitors

f) Participants with Addison’s disease.

2) Glycated hemoglobin (HbA1c) > 12% (17.5 mmol/L) at the Screening visit.

3) Participants treated with another mineralocorticoid receptor antagonist, 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.

4) Participation in another interventional clinical trial within 30 days prior to the Screening visit and during finerenone treatment.

5) Female participants who are pregnant or breast-feeding or plan to become pregnant or to breastfeed during the course of the study.

6) Participants known for lack of compliance with clinic visits or prescribed medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified