Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD (RESOLVE-CKD)
17 июня 2026 г. обновлено: Jing Chen, University of Texas Southwestern Medical Center
Reducing Inflammation to Improve Vascular and Bone Outcomes With Low-dose Colchicine in CKD: A Pilot Randomized Open-Label Trial (RESOLVE-CKD Trial)
The overall objective of this pilot randomized clinical trial is to determine whether low-dose Colchicine (LoDoCo) improves vascular disease including vascular calcification, peripheral arterial disease (PAD), and chronic kidney disease-mineral and bone disorder (CKD-MBD) biomarkers in patients with chronic kidney disease (CKD) stage 3 over a 12-month intervention period, compared with usual care.
Successful completion of this study will generate critical preliminary data to support a larger clinical trial aimed at evaluating inflammation-targeted therapies to mitigate CKD-MBD, including vascular calcification and related PAD, as well as osteoporosis, ultimately reducing cardiovascular events and mortality in patients with CKD. Additionally, this work has the potential to redefine the diagnostic framework for CKD-MBD.
Обзор исследования
Статус
Еще не набирают
Условия
Вмешательство/лечение
Подробное описание
The investigators will conduct a randomized, open-label, outcome blinded mechanistic clinical trial in 60 adults with stage 3 chronic kidney disease (CKD) who have hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD).
The investigators will evaluate whether low-dose Colchicine (LoDoCo) improves coronary artery calcification (CAC) and mineral and bone disorders (MBD) over 12 months in patients with CKD, eGFR ≥30 to 59 mL/min/1.73 m², and urine albumin-to-creatinine ratio (uACR) ≥200 mg/g. Sixty participants with CKD stage 3 and increased risk of, or established, ASCVD will be randomized 1:1 to receive LoDoCo plus usual care or usual care alone. Primary outcomes include changes in Agaston scores assessed by cardiac computed tomography (CCT) from baseline to 12 months, second outcomes include changes in the individual biomarkers of MBD and vascular calcification (VC) from baseline and 12 months. Exploratory outcomes include changes in uACR, estimated glomerular filtration rate (eGFR), ankle-brachial index (ABI), and toe-brachial index (TBI). Safety and tolerability will also be evaluated. Participants will be followed at baseline, 6 months, and 12 months for data collection, with an in-person visit at 1 month for safety evaluation. Additional safety assessments for side effects may be conducted by phone at any time.
Тип исследования
Интервенционный
Регистрация (Оцененный)
60
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: Paola Lanza, MD
- Номер телефона: 469-852-9550
- Электронная почта: paola.lanza@UTSouthwestern.edu
Учебное резервное копирование контактов
- Имя: Alexandra R Hartman
- Номер телефона: 614-420-1186
- Электронная почта: RESOLVE-CKD@UTSouthwestern.edu
Места учебы
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Texas
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Dallas, Texas, Соединенные Штаты, 75390
- University of Texas Southwestern Medical Center
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Главный следователь:
- Jing Chen, MD
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Контакт:
- Paola Lanza, MD
- Номер телефона: 469-852-9550
- Электронная почта: paola.lanza@UTSouthwestern.edu
-
Контакт:
- Alexandra R Hartman
- Номер телефона: 214-645-8294
- Электронная почта: alexandra.hartman@UTSouthwestern.edu
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-
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:
- Men and women aged 18-<70 years of all race/ethnicity groups
- CKD stage 3 (estimated glomerular filtration rate (eGFR) >30 to 59 ml/min/1.73m2)
- Urine albumin-to-creatinine ratio (uACR) ≥ 200 mg/g
- Cardiac artery calcification (CAC) Agatston score ≥30
- Hypertension, diabetes, dyslipidemia, or established atherosclerotic cardiovascular disease (ASCVD) (coronary artery disease (CAD), ischemic stroke, and peripheral artery disease), defined by self-report, ICD-10 codes, or the use of medications for these conditions.
- Ability to provide informed consent.
Exclusion Criteria:
- Current Colchicine therapy
- Hepatic disease
- Any clinically active diagnosed infection requiring systemic antimicrobial therapy, positive microbiologic evidence of infection, or infection-related hospitalization within 30 days prior to study enrollment.
- Immunosuppression
- Current use of chemotherapy drugs or active cancer
- Pregnancy/breastfeeding
- Hospitalized within the past 6 months
- Allergic/intolerance to colchicine
- Use of P-glycoprotein (p-gp) inhibitor (such as Verapamil, Quinidine, Amiodarone, Ritonavir, Lopinavir/ritonavir, Saquinavir, Nelfinavir)
- Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (such as Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Clarithromycin, Erythromycin)
- Human immunodeficiency virus (HIV) infection
- Gout attack ≥ 1 time per year
- Severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men)
- eGFR <30 ml/min/1.73m2
- uACR <200 mg/g
- White blood cell count (WBC) <3.0 x109/L
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
- Total bilirubin >2 x ULN
- Glucose >300mg/dl
- Uses nicotine products or other recreational drugs
- Unable to read or speak English
- Participant in other conflict clinical trial,
- Unable to complete the study measurements
- Unable to undergo to computed tomography (CT) or dual-energy X-ray absorptiometry (DXA) scans
- Unsafe to participate in this study per investigator's judgement.
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: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Low-Dose Colchicine (LoDoCo)
Participants will receive low-dose Colchicine (LoDoCo) in addition to usual care.
|
Intervention group will receive LoDoCo (Colchicine 0.5mg), oral, once daily.
Другие имена:
Participants will receive usual care according to standard clinical practice and treating physician discretion.
|
|
Активный компаратор: Usual Care
Participants will receive usual care alone.
|
Participants will receive usual care according to standard clinical practice and treating physician discretion.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Coronary Artery Calcification Agatston Scores
Временное ограничение: Baseline, 12 months
|
Agatston scores (Agatston units) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
Coronary artery calcification will be quantified using the Coronary Artery Calcium (CAC) Agatston Score.
Scores range from 0 Agatston units (no detectable coronary calcification), 1-99 Agatston units (mild calcification), 100-399 Agatston units (moderate calcification), and ≥400 Agatston units (severe calcification, high atherosclerotic burden).
Higher scores indicate greater coronary artery calcification and are associated with worse outcomes.
|
Baseline, 12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Coronary Artery Calcification Volume Scores
Временное ограничение: Baseline, 12 months
|
Change in Coronary Artery Calcification volume (mm3) will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
|
Baseline, 12 months
|
|
Change in Cardiac Artery Calcification Mass Scores
Временное ограничение: Baseline, 12 months
|
Change in Cardiac Artery Calcification Mass (mg) score will be measured by non-contrast cardiac computed tomography (CCT) scans following standard cardiac imaging protocols.
|
Baseline, 12 months
|
|
Change in Serum Klotho Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating klotho levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Fetuin A Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating fetuin A levels (ng/mL) will be measured using standard clinical laboratory assays
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Baseline, 6 months, 12 months
|
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Change in Serum Phosphate levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Serum Calcium Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Parathyroid Hormone (PTH) levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in C-terminal Fibroblast Growth Factor 23 (FGF23) Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays.
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Baseline, 6 months, 12 months
|
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Change in Fibroblast Growth Factor 23 (FGF23) Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Bone-Specific Alkaline Phosphatase (BSAP) Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating serum BSAP levels (ug/L) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in C-terminal Telopeptide of Type I Collagen (CTX)
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating CTX levels (ng/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Tartrate-Resistant Acid Phosphatase 5b (TRAP-5b) Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating TRAP-5b levels (U/L) will be measured using standard clinical laboratory assays
|
Baseline, 6 months, 12 months
|
|
Change in Sclerostin Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating sclerostin levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Lumbar Spine Bone Mineral Density (BMD)
Временное ограничение: Baseline, 12 months
|
BMD at the lumbar spine (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
|
Baseline, 12 months
|
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Change in Hip Bone Mineral Density (BMD)
Временное ограничение: Baseline, 12 months
|
BMD at the hip (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard manufacturer protocols.
|
Baseline, 12 months
|
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Change in Radius Bone Mineral Density (BMD)
Временное ограничение: Baseline, 12 months
|
BMD at the radius (g/cm2) will be measured by Hologic or GE Lunar DXA system following standard man
|
Baseline, 12 months
|
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Change in Interleukin-6 (IL-6) Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating IL-6 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating sTNFR1 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
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Change in Interleukin-17 (IL-17) Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating IL-17 levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Change in Intact N-Terminal Propeptide of Type I Procollagen (P1NP) Levels
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating P1NP levels (pg/mL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Exploratory: Change in Urine Albumin-to-Creatine Ratio (uACR)
Временное ограничение: Baseline, 6 months, 12 months
|
Circulating urinary albumin and creatine levels (mg/dL) will be measured using standard clinical laboratory assays.
|
Baseline, 6 months, 12 months
|
|
Exploratory: Change in Estimated Glomerular Filtration Rate (eGFR)
Временное ограничение: Baseline, 6 months, 12 months
|
eGFR values (mL/min/1.73m2)
will be calculated using the NKF-ASN CKD-Epi refit formula.
|
Baseline, 6 months, 12 months
|
|
Exploratory: Change in Ankle-Brachial Index (ABI)
Временное ограничение: Baseline, 6 months, 12 months
|
ABI will be measured using semi-automated validated device (simpleABI-600CL).
ABI values range from ≤0.90 (Peripheral artery disease), 0.91-0.99
(borderline), 1.00-1.40
(normal).
ABI values >1.40 indicate non-compressible arteries, suggestive of arterial stiffness or medial calcification.
Both ABI values ≤0.90 and >1.40 are associated with worse outcomes.
|
Baseline, 6 months, 12 months
|
|
Exploratory: Change in Toe-Brachial Index (TBI)
Временное ограничение: Baseline, 6 months, 12 months
|
TBI will be measured using semi-automated validated device (simpleABI-600CL).
TBI values range from ≥0.70 (normal), 0.64-0.69
(borderline), and <0.40-0.50
(severe distal arterial disease/critical ischemia range).
TBI values <0.70 is a commonly used threshold suggestive of peripheral artery disease.
Lower TBI values are associated with worse outcomes.
|
Baseline, 6 months, 12 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Jing Chen, MD, University of Texas
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Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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- She C, Liu H. Construction and validation of a predictive model for the risk of osteoporosis in patients with chronic kidney disease based on NHANES data. PLoS One. 2025 Feb 6;20(2):e0316494. doi: 10.1371/journal.pone.0316494. eCollection 2025.
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- Geng S, Kuang Z, Peissig PL, Page D, Maursetter L, Hansen KE. Parathyroid hormone independently predicts fracture, vascular events, and death in patients with stage 3 and 4 chronic kidney disease. Osteoporos Int. 2019 Oct;30(10):2019-2025. doi: 10.1007/s00198-019-05033-3. Epub 2019 May 31.
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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 июля 2026 г.
Первичное завершение (Оцененный)
1 декабря 2027 г.
Завершение исследования (Оцененный)
31 декабря 2027 г.
Даты регистрации исследования
Первый отправленный
11 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
11 июня 2026 г.
Первый опубликованный (Действительный)
17 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
22 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Заболевания эндокринной системы
- Заболевания костей
- Заболевания опорно-двигательного аппарата
- Сосудистые заболевания
- Сердечно-сосудистые заболевания
- Патологические процессы
- Расстройства питания
- Мужские мочеполовые заболевания
- Заболевания почек
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Хроническое заболевание
- Атрибуты болезни
- Метаболические заболевания
- Нарушения метаболизма глюкозы
- Почечная недостаточность
- Болезни костей, метаболические
- Заболевания паращитовидной железы
- Нарушения липидного обмена
- Артериосклероз
- Артериальные окклюзионные заболевания
- Авитаминоз
- Дефицитные заболевания
- Недоедание
- Рахит
- Нарушения обмена кальция
- Дефицит витамина D
- Кальциноз
- Гиперпаратиреоз, вторичный
- Гиперпаратиреоз
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Гипертония
- Сахарный диабет
- Почечная недостаточность, хроническая
- Дислипидемии
- Атеросклероз
- Сосудистая кальцификация
- Хроническая болезнь почек-минеральные и костные заболевания
- Гетероциклические соединения
- Алкалоиды
- Колхицин
Другие идентификационные номера исследования
- STU20260896
- 99077 (Другой идентификатор: UT Southwestern Medical Center)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана IPD
IRB approval is required before sharing IPD.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
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. .