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Clinical Trials/EUCTR2021-003053-37-BG
EUCTR2021-003053-37-BG
Active, not recruiting
Phase 1

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

Bayer AG0 sites600 target enrollmentAugust 24, 2021
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ConditionsType II Diabetes Mellitus and Diabetic Kidney DiseaseMedDRA version: 21.1Level: PTClassification code 10061835Term: Diabetic nephropathySystem Organ Class: 10038359 - Renal and urinary disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Type II Diabetes Mellitus and Diabetic Kidney Disease
Sponsor
Bayer AG
Enrollment
600
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 24, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Bayer AG

Eligibility Criteria

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\)

Outcomes

Primary Outcomes

Not specified

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