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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
連絡先と場所
研究連絡先
研究連絡先
- 名前：Bayer Clinical Trials Contact
- 電話番号：0018888422937
- メール：clinical-trials-contact@bayer.com
研究場所
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Multiple Locations、メキシコ
- Many locations
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参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
グループ/コホートの数
コホートと介入
グループ/コホートグループ/コホート |
介入・治療介入・治療 |
|---|---|
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Finerenone
Patients initiate finerenone according to routine clinical practice. |
Follow clinical practice/administration. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evolution of the urinary albumin-to-creatinine ratio (uACR)
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of patients achieving a clinically relevant reduction in uACR
時間枠：Baseline and at months 1, 3, 6 and 12
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Defined as a relative decrease of at least 30% from baseline. |
Baseline and at months 1, 3, 6 and 12
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Magnitude of the relative change in uACR
時間枠：Baseline and at months 1, 3, 6 and 12
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Categorization of patients into response ranges <30%, 30% to <50%, and >=50% reduction from baseline. |
Baseline and at months 1, 3, 6 and 12
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Adherence and persistence to finerenone treatment
時間枠：12 months
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Adherence and persistence during follow-up under routine clinical practice conditions. |
12 months
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Safety profile of finerenone
時間枠：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
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Use of health resources
時間枠：Up to 12 months
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Consultations and laboratory studies according to information available in medical records. |
Up to 12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 23223
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。