A Study to Learn More About How Well Finerenone Works in Real-world in People With Type 2 Diabetes and Chronic Kidney Disease in Primary Care (IMSS= Instituto Mexicano Del Seguro Social) (FINE-IMSS-MX)
Clinical Profile, Treatment Patterns and Evolution of the Urinary Albumin-to-creatinine Ratio in Patients With Type 2 Diabetes and Chronic Kidney Disease Treated With Finerenone at the Primary Care of the IMSS: Observational, Prospective, Multicenter Study
The main purpose of this study is to learn how treatment with finerenone affects the urinary albumin-to-creatinine ratio (uACR), a marker of kidney health, over time in adults with type 2 diabetes and chronic kidney disease who are receiving care in primary care clinics as part of their usual medical care. The study will help researchers better understand how finerenone is used and how people respond to treatment in everyday primary care settings.
This is an observational study, which means the study does not decide or assign treatment. Participants will receive finerenone only if their primary care doctor has already decided to prescribe it as part of routine medical care. The doctor will determine the starting dose and make any dose changes based on the participant's individual needs.
All participants will be enrolled in a single study group and followed for up to 12 months after starting finerenone. Information collected during routine primary care visits may include kidney health measurements, laboratory test results, other medications, healthcare use, and any side effects experienced during treatment. Follow-up assessments are planned around Month 1, Month 3, Month 6, and Month 12. Information about adverse events will be collected until 30 days after the participant's last dose of finerenone. The study will not require additional treatment decisions beyond routine care and aims to understand how finerenone performs in real-world primary care practice.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Bayer Clinical Trials Contact
- Telefonnummer: 0018888422937
- E-post: clinical-trials-contact@bayer.com
Studieorter
-
-
-
Multiple Locations, Mexiko
- Many locations
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Adult patients aged ≥18 years with T2D and CKD, of both sexes, treated in IMSS primary care units, who start treatment with finerenone as part of routine clinical practice.
Beskrivning
Inclusion Criteria:
- Adult participant - all genders (>=18 years old).
- Documented diagnosis of Type 2 diabetes (T2D), according to clinical criteria used in routine clinical practice.
- Documented diagnosis of Chronic Kidney Disease (CKD) in stages G2 to G3b, defined by an estimated glomerular filtration rate (Estimated Glomerular Filtration Rate [eGFR] >=30 and <90 mL/min/1.73 m^2 according to the information available in the clinical record).
- Baseline urinary albumin-to-creatinine ratio (uACR) value >=30 mg/g, documented at the time of inclusion in the study.
- Decision to initiate treatment with finerenone made by the physician as part of his or her routine clinical practice and independently of the patient's inclusion in the study.
- Baseline serum potassium <5.0 mmol/L, determined prior to or at the time of inclusion in the study.
- Signed informed consent.
- Prescription of finerenone within the authorized indications and in accordance with the prescribing information in force in the local market.
- No contraindications to the use of finerenone, in accordance with local marketing authorization and prescribing information in force.
Exclusion Criteria:
- Concomitant participation in an interventional clinical study involving interventions outside of routine clinical practice at any time during the follow-up period of the present study.
- Contra-indications according to the local label.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Finerenone
Patients initiate finerenone according to routine clinical practice. |
Follow clinical practice/administration. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Evolution of the urinary albumin-to-creatinine ratio (uACR)
Tidsram: Baseline and at months 1, 3, 6 and 12
|
Assessed by change from baseline at 1, 3, 6 and 12 months after initiation of finerenone treatment. |
Baseline and at months 1, 3, 6 and 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of patients achieving a clinically relevant reduction in uACR
Tidsram: Baseline and at months 1, 3, 6 and 12
|
Defined as a relative decrease of at least 30% from baseline. |
Baseline and at months 1, 3, 6 and 12
|
|
Magnitude of the relative change in uACR
Tidsram: Baseline and at months 1, 3, 6 and 12
|
Categorization of patients into response ranges <30%, 30% to <50%, and >=50% reduction from baseline. |
Baseline and at months 1, 3, 6 and 12
|
|
Adherence and persistence to finerenone treatment
Tidsram: 12 months
|
Adherence and persistence during follow-up under routine clinical practice conditions. |
12 months
|
|
Safety profile of finerenone
Tidsram: Up to 12 months
|
Occurrence of potentially treatment-related adverse events, serum potassium abnormalities, early eGFR changes, and related clinical actions. |
Up to 12 months
|
|
Use of health resources
Tidsram: Up to 12 months
|
Consultations and laboratory studies according to information available in medical records. |
Up to 12 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Sjukdomar i det endokrina systemet
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Diabetes mellitus, typ 2
- Njurinsufficiens, kronisk
- finerenon
Andra studie-ID-nummer
- 23223
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access.
As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of he portal.
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