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| Протокол № | 21177 |
| Тип: | ММКИ |
| Фаза: | III |
| РКИ № | 642 от 12 октября 2021 г. |
| Начало: | 12 октября 2021 г. |
| Окончание: | 31 марта 2026 г. |
| Пациентов: | 184 |
| Наименование протокола: | Рандомизированное, двойное слепое, многоцентровое плацебо контролируемое исследование III фазы в параллельных группах по оценке эффективности и безопасности финеренона в дополнение к стандартной терапии в отношении прогрессирования заболевания почек у пациентов с хронической болезнью почек недиабетического происхождения. FIND-CKD |
| Цель исследования: | Продемонстрировать, что финеренон в дополнение к стандартной терапии превосходит плацебо в замедлении прогрессирования болезни почек |
| Препарат(ы): | Финеренон (BAY 94-8862) |
| Лекарственная форма: | Таблетки, покрытые оболочкой, 10 мг, 20 мг |
| Разработчик: | Байер АГ |
| Страна: | Германия |
| CRO: | АО "БАЙЕР", 000000, г Москва, г Российская Федерация, 107113, г. Москва, ул. 3-я Рыбинская, д. 18, стр. 2, Россия |
| Терапевтические области: | Кардиология;Нефрология;ТЕРАПИЯ (ОБЩАЯ); |
Дополнительная информация:
ClinicalTrials.gov A Trial to Learn How Well Finerenone Works and How Safe it is in Adult Participants With Non-diabetic Chronic Kidney Disease
| Статус: | Active, not recruiting |
| Фаза: | Phase 3 |
| Начало: | 21 сентября 2021 г. |
| Окончание: | 9 февраля 2026 г. |
| Описание: | Researchers are looking for a better way to treat people who have non-diabetic chronic kidney disease (non-diabetic CKD). The trial treatment, finerenone, is being developed to help people who have long lasting kidney disease, also known as chronic kidney disease (CKD). It works by blocking a certain hormone called aldosterone that causes injury and inflammation in the heart and kidney which is known to play a role in CKD. In this trial, the researchers want to learn if finerenone helps to slow down the worsening of the participants' non-diabetic CKD compared to a placebo. A placebo looks like a trial treatment but does not have any medicine in it. The trial will include about 1,580 men and women who are at least 18 years old. The participants will take finerenone or a placebo once a day as tablets by mouth. All of the participants will also continue to take their current medicine for their CKD. The participants will be in the trial for up to about 50 months. During the trial, the doctors will collect blood and urine samples and check the participants' health. The participants will also answer questions about how they are feeling and what adverse events they are having. An adverse event is a medical problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the trial treatments. |
| смотреть на ClinicalTrials.gov |