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

JRCT ID: jRCT2071210061

Registered date:14/09/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease /Type 2 Diabetes Mellitus
• Date of first enrollment: 24/08/2021
• Target sample size: 600
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,Bulgaria,Japan,Canada,Japan,Czechia,Japan,Denmark,Japan,Hong Kong,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Republic of Netherlands,Japan,Portugal,Japan,Russian Federation,Japan,Singapore,Japan,Spain,Japan,Sweden,Japan,Taiwan,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Finerenone (BAY94-8862)
10 mg or 20 mg finerenone tablet to be given orally, once daily.
Drug: Placebo
Matching placebo to be taken orally, once daily.

Outcome(s)

Primary Outcome

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 ]
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"").

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Myoishi Masashi
• Secondary ID(s): NCT05013008