| Trial ID: | L1285 |
| Source ID: | NCT05552339
|
| Associated Drug: |
Finerenone (Kerendia, Bay94-8862)
|
| Title: |
A Study Called SMART-Finder to Look for People With Increased Amounts of Albumin in the Urine (UACR Level) in a Group of Type 2 Diabetes Mellitus Patients
|
| Acronym: |
SMART-Finder
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Chronic Kidney Disease
|
| Interventions: |
DRUG: Finerenone (Kerendia, BAY94-8862)|DRUG: Type 2 DM drugs
|
| Outcome Measures: |
Primary: Number of patients with Urine albumin-creatinine ratio (UACR) values between 30 and 299 mg/g and above 300 mg/g, The urine albumin-creatinine ratio (UACR) measured by a healthcare professional and provided to the patient, Up to 15 months after the date the initial UACR test took place | Secondary: Number of patients changing their UACR values regarding their baseline Albumin-Creatinine-Ratio (ACR) classification., Up to 15 months after the date the initial UACR test took place|Number of patients with hypertension and nephrotoxic co-medication, 12 month previous informed consent date until end of observation|Mean EuroQol-5 Dimensions (EQ-5D), Up to 15 months after the date the initial UACR test took place|Diabetes Treatment Satisfaction Questionnaire (DTSQ), Up to 15 months after the date the initial UACR test took place|Number of patients with CKD, Hypertension, Type 2 Diabetes Mellitus and tobacco use, Up to 15 months after the date the initial UACR test took place|Adherence - number of patients compliant and persistent in the observation period, Patients included: 1. documenting at least 80% of the expected medication tracked in myTherapy App (compliance), and 2. not stopping using their medication (persistence)., 12 month previous informed consent date until end of observation|Number of Health Care Professionals (HCPs) providing UACR to patients, Up to 15 months after the date the initial UACR test took place|Location of HCP, Up to 15 months after the date the initial UACR test took place
|
| Sponsor/Collaborators: |
Sponsor: Bayer
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
5000
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2023-08-18
|
| Completion Date: |
2025-11-18
|
| Results First Posted: |
|
| Last Update Posted: |
2025-04-11
|
| Locations: |
Many locations, Multiple Locations, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT05552339
|
