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Набор скоро начнётся NCT07235891

Retinal Protective Effects of Novel Finerenone in Patients With Chronic Kidney Disease

Фаза IV С лечением Retinal Nerve Fiber Layer Thickness Chronic Kidney Disease

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: Finerenone.
Кому может быть актуально
Состояния в реестре: Retinal Nerve Fiber Layer Thickness, Chronic Kidney Disease. Базовые параметры: от 18 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
Египет
Следующий шаг
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Официальное название

Investigating the Impact of Finerenone on Retinal Vascular Dysfunction in Patients With Chronic Kidney Disease

Обзор

Interestingly, A hypothesis-generating analysis was conducted from two studies using routine ophthalmological examinations from clinical trial participants (ReFineDR/DeFineDR), suggesting a potential benefit of finerenone in the delay of progression of non-proliferative diabetic retinopathy (NPDR), independent of baseline HbA1c. Potential benefits of finerenone were also observed in the prevention of required ocular interventions. However, the studies relied on routine ophthalmological examinations done retrospectively, which may have affected data quality and certainly affected quantity. Hence, there is a compelling need to conduct randomized studies with adequate power to detect a potential benefit of finerenone in delaying retinopathy progression, particularly given the lack of alternative options for oral treatment of retinopathy.

Подробное описание

An Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial to elucidate the difference in field vision and optical coherence tomography (OCT) metrics 1 month, 3 months and 6 months after treatment initiation compared to baseline findings; OCT metrics include macular thickness, retinal thickness, choroidal thickness, macular ganglion cell-inner plexiform layer and retinal nerve fiber layer (RNFL) thickness.

• According to literature, patients with chronic kidney disease have choroidal and retinal thinning compared to matched healthy volunteers, that's why it is interesting to investigate the potential benefit of finerenone on their retinal metrics.

Both study groups (treatment group) and (control group) will undergo ocular examinations (OCT and field of vision) in addition to blood and urine samples to be obtained at baseline, and at different follow up periods (1 month, 3 months and 6 months).

• Delta changes in field vision and optical coherence tomography (OCT) metrics 1 month, 3 months and 6 months after treatment initiation compared to baseline findings and also between groups will be measured.

Additionally,

* Mean change from baseline scores of routine laboratory investigations of CKD patients including serum creatinine, urea, uric acid, urinary Albumin to creatinine ratio (ACR). * Mean change from baseline values of metabolic parameters including random blood glucose (RBG), glycated hemoglobin (HbA1C), lipid profile and liver enzymes (ALT and AST). In addition to mean change in body weight. * To examine the metabolic regulatory effects exhibited by finerenone by measuring the mean change from baseline levels of adipokine leptin.

Вмешательства

  • Препарат Finerenone
    Finerenone, a novel orally administered selective non-steroidal MRA demonstrates stronger affinity to the mineralocorticoid receptor (MR) in comparison with eplerenone and spironolactone resulting in better efficacy in aldosterone's inhibition.

Первичные конечные точки

  • Retinal protection [Срок оценки: 6 months]
Вторичные конечные точки (2)
  • CKD progression [Срок оценки: 6 months]
  • Safety assessment (Number of patients with adverse events) [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Age: above 18 years
  • Diabetic and non-diabetic non-hemodialysis CKD patients (Stage 2 - Stage 4).

Критерии исключения

  • Patients on hemodialysis (HD).
  • Serum potassium level > 5.5 mEq/L
  • Prior/planned ocular interventions (retinal laser treatment, intravitreal injection or vitrectomy).
  • Pregnant and lactating women
  • Malignancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Alexandria University — Alexandria

Идентификаторы

NCT: NCT07235891 · 0202162

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗