Идёт набор NCT05099770

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Фаза III С лечением Type 2 Diabetes Mellitus Chronic Kidney Diseases

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: Renal Autologous Cell Therapy (REACT/ rilparencel), Sham Comparator.
Кому может быть актуально: Состояния в реестре: Type 2 Diabetes Mellitus, Chronic Kidney Diseases. Базовые параметры: 30 лет — 80 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: США, Австралия, Канада, Мексика, Пуэрто-Рико +2
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

A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

Обзор

The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.

Подробное описание

Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will have scripted sham procedures that mimic the sounds and activities of biopsy, injection procedures, and evaluations as a control for Cohort 2 participants who will have a kidney biopsy followed with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later with a second rilparencel injection into the contralateral kidney. All participants will be followed until the global trial end date is declared.

Вмешательства

Биопрепарат Renal Autologous Cell Therapy (REACT/ rilparencel)
Participants will have a kidney biopsy followed approximately12 weeks later with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later a rilparencel injection into their contralateral kidney.
Процедура Sham Comparator
Participants will have sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The 2 injection/ sham procedures will occur approximately 12 weeks apart.

Первичные конечные точки

Surrogate / Intermediate Efficacy Endpoint -eGFR Slope [Срок оценки: 18 months after the 135th participant receives their first injection / sham.]
Clinical Endpoint [Срок оценки: From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.]

Вторичные конечные точки (5)

Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days. [Срок оценки: From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.]
Secondary Endpoint: Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant. [Срок оценки: From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.]
Secondary Endpoint: All-cause mortality. [Срок оценки: From date of first injection to all-cause mortality assessed up to 94 months.]
Secondary Endpoint: Kidney Disease Quality of Life Changes [Срок оценки: Week 52]
Secondary Endpoint: Quality of Life [Срок оценки: Week 52]

Критерии участия

Критерии включения

The participant is male or female, 30 to 80 years of age on the date of informed consent.
Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease
Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening.
Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening.
All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i).
On a clinically relevant, maximally tolerated dose of an angiotensin converting-enzyme inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or contraindicated.
Participant agrees and is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and post-procedure durations.
Participant is willing and able to cooperate with all aspects of the protocol and provide signed informed consent.

Критерии исключения

The participant has a history of type 1 diabetes mellitus.
The participant has a history of renal transplantation or other organ transplantation
The participant has any other known underlying cause of kidney disease
History of acute kidney injury or major surgery within 3 months prior to the Screening Visit.
Myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial.
Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease.
History of exclusionary malignancy within the past 3 years prior to Screening
Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C.
Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.
Immunocompromised condition or condition requiring chronic immunosuppressive agents, including individuals treated for chronic glomerulonephritis, within 3 months of signing ICF.
Has had a recent bleeding event or a known bleeding disorder(s) or increased risk of either thromboembolism or bleeding.
Kidney imaging reveals contraindications for undergoing biopsy or rilparencel injection
Maintained on any anticoagulant agents
History of anaphylactic or severe systemic reaction(s) to blood transfusions, Dextran 40, or bovine products, or contraindication(s) to above products due to medical reasons or participant preference.
History of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
Use of an investigational product or device within 12 weeks prior to Randomization or previous treatment with rilparencel.
Participant's health status would, in the judgement of the Investigator, be jeopardized by participating in the study.

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: Тройное слепое
Основная цель: Лечение