Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: Finerenone: Finerenone 10/20mg OD, Route of administration is Oral. Duration of treatment is 6 months
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Bayer Zydus Pharma Private Limited (BZPPL) India
Eligibility
Inclusion criteria
Inclusion criteria: Patients from India (Indian ethnicity) diagnosed with CKD and T2D prior to initiating finerenone (per the standard diagnostic criteria) and initiated on finerenone per approved label. Patient was prescribed finerenone for the first time (drug naive) for the management of CKD and T2D between 1st August 2022 and 30th April 2024.Age 18 years or older at the time of finerenone initiation.
Exclusion criteria
Exclusion criteria: Patients with the following recorded data (on or within 90 days before finerenone initiation) will be excluded: eGFR less than 25 mL per min per 1.73 metre square Serum potassium more than 5.0 mmol per Litre Type 1 diabetes is recorded in the patient record Contraindications according to the local marketing authorization Patient data will be excluded if below information is identified in the patient record at any point from index date to the end of observation period: Pregnancy. Lactation. Patient taking concomitant medications that are strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin and nefazodone). Addisons disease. Patient was a part of an interventional clinical study between 1st August 2022 and 30th Nov 2024.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| • Assess absolute and relative changes in serum potassium and key measures of kidney function -urine albumin-to-creatinine ratio UACR and eGFR over time after initiation of finerenone. • Describe the occurrence of hyperkalemia hospitalization and dialysis due to hyperkalemia after initiating finerenone.Timepoint: 6 months | — |
Primary
| Measure | Time frame |
|---|---|
| Describe demographic and clinical characteristics comorbidities comedications and finerenone drug utilization patterns in patients with chronic kidney disease and Type 2 Diabetes treated with finerenone in routine clinical practice in India.Timepoint: Patient information will be captured and entered the eCRF covering the baseline period, from 6 months prior to index until finerenone initiation (index), and during follow-up from 1 day after index until 30 November 2024 (or patient censorship) | — |
Countries
India
Contacts
Public ContactDr Pravin Manjrekar
Bayer Pharmaceuticals Private Limited
Outcome results
None listed