Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Empagliflozin.
- Кому может быть актуально
- Состояния в реестре: Chronic Kidney Disease. Базовые параметры: от 16 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin
Обзор
This prospective observational study aims to assess the association between real-world use of sodium-glucose co-transporter 2 inhibitors (SGLT2i; e.g., empagliflozin, dapagliflozin) and renal function decline in adults with chronic kidney disease (CKD) stages 2-4 (KDIGO classification). The study will also validate a urinary biomarker panel for early diagnosis and monitoring of CKD progression. No investigational product is assigned, and medical practice or prescription patterns are not altered.
Подробное описание
This is a real-world, observational study with prospective follow-up and retrospective baseline data when available, conducted at the Nephrology Department of the University Hospital of Salamanca, Spain.
The project integrates translational and clinical components:
1. validation of a urinary biomarker panel obtained through differential proteomics for early detection and monitoring of CKD progression, and 2. evaluation of the effectiveness and safety of SGLT2i in routine clinical practice.
A total of 300 adults with CKD stages 2-4 will be included (150 initiating SGLT2i and 150 matched controls). Participants will be followed for 12 months (baseline, 6, and 12 months). Data will be extracted exclusively from electronic health records and laboratory systems.
The primary outcome is the annual decline rate of estimated glomerular filtration rate (eGFR, CKD-EPI 2021). Secondary outcomes include a composite renal endpoint (≥40% sustained eGFR decline, renal replacement therapy, transplantation, or renal death), cardiovascular hospitalization, all-cause mortality, adverse drug reactions (ADRs), and real-world patterns of SGLT2i use.
Exploratory analyses will assess associations between urinary biomarkers and clinical outcomes.
The study follows Spanish regulations for observational studies with medicinal products (Real Decreto 957/2020), with ethics approval and informed consent for biological samples.
Вмешательства
- Препарат Empagliflozin
Oral empagliflozin (10-25 mg daily) for 12 months
Первичные конечные точки
- Change in urinary biomarker panel expression (proteomic fingerprint) [Срок оценки: Baseline, 6 months, 12 months]
Вторичные конечные точки (12)
- Change in estimated glomerular filtration rate (eGFR) [Срок оценки: Baseline, 6 months, 12 months]
- Histopathological improvement of renal tissue (animal study) [Срок оценки: Monthly up to 9 months]
- Monitoring of adverse events of empagliflozin in CKD patients without diabetes [Срок оценки: From baseline to 12 months]
- Change in estimated glomerular filtration rate (eGFR) [Срок оценки: From baseline to 12 months]
- Change in serum creatinine [Срок оценки: From baselinte to 12 months]
- Change in urinary albumin-to-creatinine ratio [Срок оценки: From baseline to 12 months]
- Change in serum electrolyte levels [Срок оценки: From baseline to 12 months]
- Change in liver function tests [Срок оценки: From baseline to 12 months]
- Change in glycated hemoglobin (HbA1c) [Срок оценки: From baseline to 12 months.]
- Change in hematological parameters [Срок оценки: From baseline to 12 months]
- Change in blood pressure [Срок оценки: From baseline to 12 months]
- Change in body weight [Срок оценки: From baseline to 12 months]
Критерии участия
Критерии включения
- ≥18 years old
- Diagnosed with chronic kidney disease (KDIGO stages 2-4)
- Life expectancy ≥12 months
- Available clinical and laboratory data in the electronic medical record
Критерии исключения
- Current or recent renal replacement therapy or kidney transplantation
- End-stage renal disease
- Participation in interventional trials that may affect outcomes
- Allergy or intolerance to SGLT2i (for exposed cohort)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Испания · 1 центр
- Hospital Universitario de Salamanca — Salamanca
Идентификаторы
NCT: NCT07348484 · PI25/00053