Finerenone for the Treatment of Type 2 Diabetes-Related Kidney Disease: Efficacy Observation and Related Factor Analysis
This is a single-center prospective observational clinical study conducted at the First Affiliated Hospital of Chongqing Medical University. A total of 425 patients aged 18-75 years with type 2 diabetes mellitus-related chronic kidney disease will be enrolled from February 2026 to January 2029. All participants will receive standard finerenone treatment in accordance with clinical guidelines with a 4-month follow-up period. Blood and urine samples will be collected at screening, baseline, 1 month, 2 months and 4 months after treatment initiation for routine biochemistry, aldosterone/renin testing, captopril suppression test and multi-omics analysis.
Participants will be categorized into benefit group, partial benefit group and non-benefit group based on the reduction rate of urine albumin-to-creatinine ratio (UACR) at Month 4. We will combine demographic data, laboratory indicators and multi-omics profiles to identify key biomarkers predicting finerenone response, and construct a predictive model to realize precise individualized therapy for diabetic kidney disease.
All study-related laboratory tests are free of charge for subjects. A priority consultation channel is available during follow-up, and free professional consultation on diabetic nephropathy will be provided. Serum potassium and renal function will be closely monitored to manage safety risks such as hyperkalemia. All personal data and biological samples are anonymized and stored in encrypted systems with strict confidentiality protection. Subjects may withdraw from the study voluntarily at any time without interference to their routine clinical care.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This single-center prospective observational cohort study will recruit 425 eligible adult patients aged 18-75 years diagnosed with type 2 diabetes mellitus associated chronic kidney disease (T2DM-CKD) from the Chongqing Diabetes Registry, endocrine wards and outpatient clinics of the First Affiliated Hospital of Chongqing Medical University between February 2026 and January 2029. All enrolled subjects will receive guideline-directed finerenone oral therapy for a 4-month observation period, with dose adjusted based on baseline eGFR and serum potassium levels per drug instructions.
Serial blood and urine biospecimens will be collected at screening, baseline, month 1, month 2 and month 4 visits. Collected samples will be tested for routine biochemistry, electrolytes, renal function, HbA1c, plasma renin and aldosterone; captopril suppression test and multi-omics profiling will also be performed at designated time points.
According to the percentage reduction of urine albumin-to-creatinine ratio (UACR) at month 4, participants will be stratified into three subgroups: benefit group (UACR reduction ≥30%), partial benefit group (10% ≤ UACR reduction <30%), and non-benefit group (UACR reduction <10% or elevated UACR). Primary objective is to identify core biomarkers associated with finerenone therapeutic response. Secondary outcomes include serial changes in eGFR, UACR, serum potassium, aldosterone and renin across all follow-up time points.
Sample size calculation was performed using R pmsampsize package, accounting for a 10% anticipated loss to follow-up to reach the target sample of 425 subjects. All statistical analyses will be conducted via R and Python with machine learning algorithms to develop and validate a predictive model for finerenone efficacy.
Safety monitoring including serum potassium and renal function assessment will be conducted at every visit. Subjects with hyperkalemia or progressive renal impairment will suspend finerenone per predefined criteria. All study-related laboratory examinations are provided free of charge to participants, with priority medical consultation service available throughout follow-up. All personal clinical data and biological samples are anonymized and stored under encrypted management to protect participant privacy. Subjects may withdraw consent at any time without impact on routine clinical treatment. Study findings will be summarized and published in peer-reviewed journals after data collection is fully completed.
Тип исследования
Регистрация (Оцененный)
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
This is a prospective observational cohort study enrolling patients with type 2 diabetes mellitus (T2DM) complicated with chronic kidney disease (CKD) receiving finerenone therapy. Subjects will be recruited from the Chongqing Diabetes Registry (CDR), endocrine outpatient and inpatient departments of the First Affiliated Hospital of Chongqing Medical University, with a recruitment window from February 2026 to January 2029. A total of 425 eligible participants are planned to be enrolled.
A target sample size of 425 participants is determined using the R pmsampsize package for predictive model development. Key input parameters: C-statistic of 0.80, 10 candidate predictive variables, expected finerenone responder proportion of 53.2% derived from FIDELIO-DKD and FIGARO-DKD trials. The minimum required sample size to satisfy model stability and calibration criteria is 383 participants. A 10% attrition rate is accounted for, leading to the final enrolment target of 425 patients.
Описание
Inclusion Criteria:
- Aged 18-75 years, male or female, with full capacity for independent conduct.
- Confirmed type 2 diabetes-associated chronic kidney disease (CKD): Random urine albumin-to-creatinine ratio (UACR) of 100-5000 ug/mg Cr on two non-consecutive days; estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI formula >25 mL/min/1.73m²; Finerenone treatment is indicated per clinical guidelines.
- All concomitant medications have remained stable for 3 months prior to screening, with no planned treatment adjustments throughout the trial. Stable medication is defined as dose adjustments not exceeding ±25% of the screening baseline dose.
- If the glycemic regimen includes sodium-glucose cotransporter 2 inhibitors (SGLT-2i): The daily SGLT-2i dose remains constant for 3 months before screening, and no daily dose changes are planned during the entire trial. If the glycemic regimen excludes SGLT-2i: No SGLT-2i exposure within 4 weeks prior to screening, and no SGLT-2i initiation is planned throughout the trial.
- If the glycemic regimen includes glucagon-like peptide-1 receptor agonists (GLP-1RA): The daily GLP-1RA dose remains constant for 3 months before screening, and no daily dose changes are planned during the entire trial. If the glycemic regimen excludes GLP-1RA: No GLP-1RA exposure within 4 weeks prior to screening, and no GLP-1RA initiation is planned throughout the trial.
- Fully understands the entire trial procedure, voluntarily participates in the study and signs the informed consent form.
Exclusion Criteria:
- Diagnosed or suspected type 1 diabetes, special type diabetes or secondary diabetes.
- Poor glycemic control with glycated hemoglobin (HbA1c) >9.0%.
- Average seated office blood pressure measured over 3 visits with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg.
- Serum potassium >5.0 mmol/L without potassium supplementation.
- Diagnosed or suspected chronic kidney disease unrelated to diabetic nephropathy.
- Complicated with liver cirrhosis or moderate-to-severe liver impairment.
- Patients with secondary aldosteronism and primary aldosteronism who have surgery plans within six months.
- Confirmed Addison's disease.
- Complicated with uncontrolled autoimmune diseases.
- Complicated with active malignant tumors.
- Presence or suspicion of depression, bipolar disorder, suicidal tendency, schizophrenia or other severe mental illnesses; or lack of mental capacity or language barrier, unable to fully understand the trial protocol or unwilling to cooperate with study site staff.
- Complicated with other uncontrolled chronic diseases.
- Use of serum potassium-elevating agents (e.g., amiloride, triamterene) or other mineralocorticoid receptor antagonists (MRAs, e.g., spironolactone, eplerenone) within 4 weeks prior to screening.
- Use of strong CYP3A4 inhibitors (itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone) or CYP3A4 inducers (carbamazepine, phenytoin, erythromycin, fluvoxamine) within 2 weeks prior to screening.
- Pregnant or breastfeeding women.
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Finerenone Treatment Cohort
All enrolled participants with type 2 diabetes mellitus-related chronic kidney disease receive guideline-standard oral finerenone therapy for a 4-month observation period.
The finerenone dose is adjusted according to each subject's baseline eGFR and serum potassium level following the official drug instructions.
Concomitant hypoglycemic, antihypertensive and lipid-lowering medications remain stable during the whole study period as required by inclusion criteria.
Serial blood and urine biospecimens are collected at multiple follow-up time points for routine biochemical tests, captopril suppression test and multi-omics detection.
After 4 months of treatment, subjects will be divided into three analytic subgroups based on UACR reduction rate to explore predictive biomarkers of finerenone efficacy.
|
Oral finerenone administered once daily for 4 months.
Dosage is individualized based on baseline estimated glomerular filtration rate (eGFR) and serum potassium per drug labeling.
Subjects maintain stable background hypoglycemic, antihypertensive and lipid-lowering therapies throughout the observational period.
No additional study-specific drugs or experimental procedures are applied; only routine clinical finerenone treatment is observed with serial blood and urine sample collection for multi-omics and biomarker analysis.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Key biomarkers associated with therapeutic response to finerenone
Временное ограничение: 4 months after finerenone initiation
|
Identify core multi-omics, biochemical and clinical biomarkers that predict whether patients with type 2 diabetes-related chronic kidney disease can achieve renal benefit from finerenone treatment.
|
4 months after finerenone initiation
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage change in urine albumin-to-creatinine ratio (UACR) from baseline to Month 4
Временное ограничение: Baseline, Month 4
|
Stratify participants into benefit (UACR reduction ≥30%), partial benefit (10% ≤ UACR reduction <30%), non-benefit (reduction <10% or increased UACR) based on UACR decline at Month 4.
|
Baseline, Month 4
|
|
Serial change in estimated glomerular filtration rate (eGFR)
Временное ограничение: Baseline, Month 1, Month 2, Month 4
|
Dynamic variation of eGFR at each follow-up visit compared with baseline.
|
Baseline, Month 1, Month 2, Month 4
|
|
Serial change in serum potassium
Временное ограничение: Baseline, Month 1, Month 2, Month 4
|
Continuous monitoring of serum potassium to assess the risk of hyperkalemia during finerenone treatment.
|
Baseline, Month 1, Month 2, Month 4
|
|
Changes in plasma aldosterone and renin at Month 4
Временное ограничение: Baseline, Month 4
|
Difference of plasma aldosterone and renin levels between baseline and Month 4 after finerenone intervention.
|
Baseline, Month 4
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Заболевания эндокринной системы
- Мужские мочеполовые заболевания
- Заболевания почек
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Метаболические заболевания
- Нарушения метаболизма глюкозы
- Сахарный диабет
- Осложнения диабета
- Пищевые и метаболические заболевания
- Сахарный диабет, тип 2
- Диабетические нефропатии
- finerenone
Другие идентификационные номера исследования
- 2026-0256-01
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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