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Precision T1D Platform - New Therapies for Cardio-Renal Complications

5 августа 2026 г. обновлено: Rodica Busui, Oregon Health and Science University

Accelerating Breakthrough Targeted New Therapies for Cardio-Renal Complications in People With T1D (Precision T1D Platform)

Breakthrough T1D has awarded support for a joint University of Michigan-Oregon Health & Science University Center of Excellence (CoE) to address cardio-renal complications in T1D. The overarching hypothesis of the CoE is that individuals with T1D have unique endophenotypes determining their progression towards cardio-renal end organ damage. Defining the underlying molecular programs in T1D endophenotypes provides the rationale for testing existing or new drug candidates in mechanistic trials targeting T1D cardio-renal complications by matching endophenotypes to targeted therapies.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

This is a multicenter, open label pilot platform study to evaluate the impact of allocating patients with T1D and early signs of HF/DKD to targeted therapies based on their disease pathway activation signatures. The hypothesis is that stratifying T1D patients by molecularly-defined endophenotypes enables the use of targeted therapies that can more effectively prevent or slow cardio-renal complications.

There is no randomized allocation to treatment arms; rather, the eligible participant's clinical and biomarker data will be reviewed by the Molecular T1D Board which will adjudicate each participant to a treatment arm based on their based on their disease pathway activation signatures. Activation of different treatment arms may be initiated at different time points during the study.

The following sections describe the master protocol, outlining the requirements across all treatment arms, including the study-wide inclusion and exclusion criteria and study-wide procedures. Appendix A outlines any treatment arm/investigational agent specific information, including defining additional treatment-specific eligibility criteria and required study procedures.

The study schema can be found in Section 1.2 and the Schedule of Activities (SoA) in Section 1.3. Potential participants will undergo a two-part consent and screening process. The initial consent and screening visit will be limited to activities necessary for assessment by the Molecular T1D Board. Following review by the Molecular T1D Board, participants will be adjudicated to one treatment arm. At this time, participants will undergo the second consent and screening step, which will include information about specific requirements for their assigned investigational arm and, if in agreement, a complete eligibility assessment via a full screening visit. If the participant is deemed eligible, they will be notified and investigational product will be mailed to them directly. The screening visit results will also serve as the baseline results provided the first dose of study drug is taken within 14 (target) to 21 (limit) days of the screening visit. If more than 21 days, a retest of all laboratory measures will be performed.

Participants will receive open label treatment for 26 weeks, with planned study visits at weeks 2, 6, 12, 26, and 30. The total study duration of participation will be up to 36 weeks, inclusive of the screening period. Active study participation will conclude at Week 30 visit. Following completion of active study participation, participants will enter a passive follow-up period during which the study team may collect information on vital status, survival, hospitalizations, and other relevant clinical outcomes through review of medical records and other authorized data sources for up to 12 months after study participation ended. No additional protocol-required visits, procedures, or interventions will be conducted during the passive follow-up period. Participants will be enrolled in this study at Oregon Health & Science University and the University of Michigan.

The currently planned number of study arms is three, with 15-19 participants enrolled in each arm. The study sponsors will have the option to increase the number of study arms and potential targeted therapies, which would be documented in the appendices and this master protocol.

Тип исследования

Интервенционный

Регистрация (Оцененный)

57

Фаза

  • Фаза 2

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Laura Nguyen
  • Номер телефона: (971) 509-4222
  • Электронная почта: nguyelau@ohsu.edu

Учебное резервное копирование контактов

  • Имя: Aly Carlson
  • Номер телефона: (971) 610-3005
  • Электронная почта: carlsaly@ohsu.edu

Места учебы

  • Соединенные Штаты
    • Michigan
      • Ann Arbor, Michigan, Соединенные Штаты, 48109
        • University of Michigan
        • Младший исследователь:
          • Matthias Kretzler, MD
        • Контакт:
          • Hailey Desmond, MS
          • Номер телефона: (734) 764-6955
          • Электронная почта: heturner@med.umich.edu
        • Главный следователь:
          • Lynn Ang, MD
    • Oregon
      • Portland, Oregon, Соединенные Штаты, 97239
        • Oregon Health & Science University
        • Главный следователь:
          • Rodica Busui, MD, PhD
        • Младший исследователь:
          • Brian Davidson, MD
        • Контакт:
          • Laura Nguyen
          • Номер телефона: 971-509-4222
          • Электронная почта: nguyelau@ohsu.edu
        • Контакт:
          • Aly Carlson
          • Номер телефона: 971-610-3005
        • Младший исследователь:
          • Jonathan Purnell, MD
        • Младший исследователь:
          • David Ellison, MD
        • Младший исследователь:
          • Kristin Childress, MD, MPH

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

Inclusion Criteria:

  1. Diagnosis of T1D, defined as hyperglycemia requiring treatment with insulin within one year from diagnosis or, if the onset was after age 35 years, documentation of the presence of hyperglycemia and one or more of the following:

    1. presence of circulating T1D-associated autoantibodies, or
    2. history of hospitalization for diabetic ketoacidosis, or
    3. documented plasma C-peptide below the limit of detection with standard assay (with concurrent blood glucose >100 mg/dL)
  2. Aged 18-75 years, inclusive
  3. T1D duration >10 years
  4. HbA1c: 7-10%

  5. Meets one of the following, either

    1. UACR > 30 mg/dl with eGFR ≥ 60mL/min/1.73 m2 and receiving standard of care therapy for early DKD Stage 2, including renin angiotensin system blockade (RASB), unless contraindicated or not tolerated, or
    2. Early (Stage B HF) defined as NT-proBNP ≥125 pg/mL
  6. Willing and able to adhere to schedule of activities and protocol requirements, including written informed consent

Exclusion Criteria:

  1. Diagnosis of Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease
  2. Use of any active platform treatment arms outside study assignment within 2 months prior to screening. See Appendix A for active treatment arms
  3. Current use of GLP-1 receptor agonists or other non-glucose lowering agent
  4. Use of aldosterone inhibitors within 2 months prior to screening
  5. Immunosuppressive medications within 3 months prior to screening
  6. Systolic BP>160 or diastolic BP >95 mmHg at screening
  7. History of ≥3 severe hypoglycemic events requiring third-party assistance for correction within 3 months prior to screening
  8. Evidence of any episode of DKA or non-ketotic hyperosmolar state within 12 months prior to screening
  9. Serum potassium > 5.0 mmol/L at screening
  10. Absolute neutrophil count < 2.0 × 109 per L at screening
  11. Platelet count < 120 × 109 per L at screening
  12. Known active tuberculosis, hepatitis B or C at screening, or history of HIV
  13. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and/or AST or ALT >2 times upper limit of normal, and/or total bilirubin >1.3 times upper limit of normal at screening
  14. History of severe acquired immune deficiency syndrome or severely immunocompromised status in the opinion of the study site investigator
  15. History of biopsy-proven non-diabetic CKD
  16. History of any other cause of HF (viral, congenital, valvular)
  17. History of heart or renal transplant or currently on chronic dialysis
  18. Cancer treatment, excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer, within one year prior to screening
  19. Illicit drug abuse within 6 months prior to screening in the opinion of the study site investigator
  20. Current heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week)
  21. Participation in another interventional clinical research study within 30 days prior to screening
  22. Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial
  23. Presence of a clinically significant medical history, physical examination, laboratory finding or other identified study site investigator concern that may interfere with any aspect of study conduct or interpretation of results

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Finerenone
Study participants with biomarker profiles showing a match for finerenone will be adjudicated to this treatment arm. The clinically recommended dose for finerenone based on manufacturer guidelines is 20 mg once daily (oral) if screening eGFR is ≥60 mL/min/1.73 m2.
Лекарство: Finerenone
Each treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion.
Другие имена:
  • KERENDIA
Экспериментальный: Sotagliflozin
Study participants with biomarker profiles that match with sotagliflozin will be adjudicated to this treatment arm. The clinically recommended dose of sotagliflozin is 200 mg per the manufacturer guidelines. The dose of 200 mg has a lower DKA risk and similar kidney benefits to the higher doses.
Лекарство: Sotagliflozin
Each treatment arm will be a different unique drug. There will be no crossing over of participants between arms. Each participant that is adjudicated to their treatment arm will remain on that arm for the duration of the study through study completion.
Другие имена:
  • ИНПЕФА

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Markers of Renal Health [Safety and Tolerability]
Временное ограничение: 26 weeks
The primary efficacy endpoints are measures of early (week 26) outcomes on markers of renal health, defined as the percent change from baseline to week 26 in UACR.
26 weeks
Markes of Cardio Health [Safety and Tolerability]
Временное ограничение: 26 weeks
The primary efficacy endpoints are measures of early (week 26) outcomes on markers of cardio health as defined by the percent change from baseline to week 26 in NT-proBNP.
26 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Временное ограничение: 26 weeks
The primary safety endpoints are defined as incidence of serious adverse events, adverse events and clinically significant abnormal laboratory tests.
26 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Immediate Outcomes of Renal Health (week 6)
Временное ограничение: 20 weeks
The secondary endpoints are measures of immediate outcomes on markers of renal health as defined by changes from baseline to week 6 in UACR.
20 weeks
Immediate Outcomes of Cardio Health (week 6)
Временное ограничение: 20 weeks
The secondary endpoints are measures of immediate outcomes on markers of cardio health as defined by changes from baseline to week 6 in NT-proBNP.
20 weeks
Immediate (week 6) and Early (week 26) Outcomes of Nephron Function Failure
Временное ограничение: 26 weeks
The secondary endpoints are measures of immediate outcomes on markers of renal function failure as defined by changes from baseline to week 6 and from baseline to week 26 in eGFR.
26 weeks

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Oregon Health and Science University

Соавторы

University of Michigan
Breakthrough T1D

Следователи

  • Учебный стул: Rodica Busui, MD, PhD, Oregon Health and Science University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 ноября 2026 г.

Первичное завершение (Оцененный)

31 декабря 2029 г.

Завершение исследования (Оцененный)

31 декабря 2031 г.

Даты регистрации исследования

Первый отправленный

11 мая 2026 г.

Впервые представлено, что соответствует критериям контроля качества

11 мая 2026 г.

Первый опубликованный (Действительный)

18 мая 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

10 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

5 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 30027

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

A limited dataset along with other study related materials (i.e., protocol, consent template, etc.) will be shared with other researchers/investigators at other institutions such as the University of Michigan via a data use agreement initiated by the primary site, Oregon Health & Science University.

Сроки обмена IPD

The sharing of information will be available as soon as both institutions sign the data use agreement for a limited dataset. However, the sharing of protocols and consent form language are currently being shared as both institutions are collaborating to draft these documents. This collaborating is facilitated by a subaward contract between two institutions.

Критерии совместного доступа к IPD

Only study personnel working on the study will have access to study related information. All information is kept on secure share drives at each respective institution and access is only possible if the personnel is an employee with institutional specific credentials to securely log in.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • МКФ
  • АНАЛИТИЧЕСКИЙ_КОД
  • КСО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Да

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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