A non-blinded retrospective biomarker add-on study to FIGARO-DKD for Bioprofiling the pharMacodynamic response to finerenone in FIGARO-DKD subjects (FIGARO-BM)

Phase 1

• Conditions: Type II Diabetes Mellitus and Diabetic Kidney Disease; MedDRA version: 21.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-003053-37-BG
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-24
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Signed informed consent to participate in FIGARO-BM
• Randomized in the FIGARO-DKD trial
• For each participant, 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Subjects which did not show overall compliance of 80 to 120% with study intervention in FIGARO-DKD
• Subjects which were not part of the full analysis set (FAS) of FIGARO-DKD.
• Subjects with known fatal outcome
Subjects with baseline eGFR =25 mL/min/1.73m2
• Subjects with low baseline risk (normal albuminuria and eGFR=60 mL/min/1.73m2)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study aims to investigate long-term effect of finerenone treatment, in addition to standard-of-care, on circulating blood biomarkers associated with fibrosis, congestion, inflammation and vascular function.;Secondary Objective: To characterize mid- to long-term PD effects of finerenone and profiling the response to finerenone (vs placebo) in patients with DKD to describe biological pathways. ;Primary end point(s): To investigate long-term effect of finerenone treatment, in addition to standard-of-care, on circulating blood biomarkers associated with fibrosis, congestion, inflammation and vascular function;Timepoint(s) of evaluation of this end point: 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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To characterize mid- to long-term PD effects of finerenone and profiling the response to finerenone (vs placebo) in patients with DKD to describe biological pathways;Timepoint(s) of evaluation of this end point: Change in plasma biomarker levels after 12 months (Visit 5), 24 months (Visit 8) and 36 months (Visit 11) of treatment versus 4 months (Visit 3) of treatment