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

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

Центры проведения

США · 79 центров

• Nephrology Consultants — Huntsville
• University of Arizona — Tucson
• Amicis Research Center — Beverly Hills
• Paradise Clinical Research Group LLC — Glendora
• Kidney Consultants Medical Group — Granada Hills
• IMD Clinical Trials — Huntington Park
• Advanced Medical Research, LLC — Lakewood
• Medicine and Nephrology Associates — Los Alamitos
• … и ещё 71 центр

Тайвань · 9 центров

Список центров уточняется — проверьте первичный протокол.

Мексика · 2 центра

Список центров уточняется — проверьте первичный протокол.

Пуэрто-Рико · 2 центра

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Австралия · 1 центр

• St. George Hospital — Kogarah

Канада · 1 центр

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Великобритания · 1 центр

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Публикации

• Cizman B, Butler EL, Stavas J, Prakash R, Saad T, Silva A, Wooldridge T, Aqeel A, Yan H, Barysauskas CM, Culleton B. A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Jan 2;21(5):744-53. doi: 10.2215/CJN.0000000969. Online ahead of print. PMID 41481370
• Patel HA, Wang J, Zinn CJ, Learmonth M, Lerman LO, Wolfram J, Hickson LJ. Fortifying the Diabetic Kidney Disease Treatment Armamentarium: Multitarget Senotherapeutic and Regenerative Strategies. J Am Soc Nephrol. 2025 May 7;36(8):1655-1658. doi: 10.1681/ASN.0000000754. No abstract available. PMID 40333016

Идентификаторы

NCT: NCT05099770 · REGEN-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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