A Non-blinded Retrospective Biomarker add-on Study to FIGARO-DKD for Bioprofiling the Pharmacodynamic Response to Finerenone in FIGARO-DKD Subjects

Phase 2

• Conditions: Chronic Kidney Disease /Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCT2071210061
• Lead Sponsor: Myoishi Masashi

Brief Summary

The study reached its primary exploratory endpoint as >=1 biomarkers were significantly affected by finerenone treatment compared to placebo: Matrilysin, von Willebrand factor, CCN family member 4, and transforming growth factor beta-1 proprotein revealed significant differences between treatment arms after multiplicity correction.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-14
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 951

Inclusion Criteria

This study will only include participants who were enrolled in the FIGARO-DKD study (NCT02545049) and had received up to 20 mg finerenone or placebo for >=24 months.
-For each participant, pharmacokinetic (PK) plasma samples from Visit 3 and at least 2 other Visits (Visit 5, Visit 8, Visit 11) must be available on storage from the main study FIGARO-DKD.

Exclusion Criteria

-Participants which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD.
-Participants which were not part of the full analysis set (FAS) of FIGARO-DKD.
-Participants with known fatal outcome.
-Participants with baseline estimated glomerular filtration rate (eGFR) =<25 mL/min/1.73m^2.
-Participants with low baseline risk (normal albuminuria and eGFR>=60 mL/min/1.73m^2).
-Sponsor request (after discussion with the investigator), for reasons such as a significant protocol deviation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in plasma biomarker levels after 36 months (Visit 11) of treatment versus 4 months (Visit 3) of treatment in a set of 27 pre-defined biomarkers [ Time Frame: 4 months and 36 months ]<br>Blood-based biomarkers will be analyzed. The primary analyses will be carried out using the OLINK Explore assay. The list of biomarkers of primary interest consists primarily of biomarkers of inflammation and fibrosis which have been published previously in the context of inflammation-related fibrosis and CKD. The measurements will not give absolute units, and results are given in relative units similar to polymerase chain reaction (PCR) results (NPX).