- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07645599
Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function (MUST-D)
This pilot study is testing a new ultrasound imaging method called Super-Resolution Ultrasound (SRU) to look at blood flow and tiny blood vessels in transplanted kidneys in very detailed images after kidney transplant surgery. The goal is to see whether changes in the kidney's small blood vessels can help predict how well the transplanted kidney will work early after transplant, including whether delayed graft function may occur.
Investigators hope this technique can become a safe, noninvasive way to evaluate transplanted kidneys without needing as many invasive biopsies. It may also help doctors better assess donor kidneys at higher-risk of suboptimal functioning.
Обзор исследования
Статус
Условия
Подробное описание
Specific Aim 1: Utilize super-resolution ultrasound (SRU) to analyze tiny blood vessels in transplanted kidneys under very detailed imaging and evaluate kidney allografts and predict post-transplantation function.
Delayed graft function (DGF) is a common complication that can happen soon after a kidney transplant and may lead to longer recovery times and other health problems. Kidney biopsies are typically required to find the cause, which are invasive procedures. Current imaging tests cannot clearly show the tiny blood vessel changes inside the transplanted kidney that may contribute to the development of DGF.
Hypothesis: Investigators hypothesize that SRU can noninvasively predict DGF outcomes by measuring changes in the structure of tiny kidney blood vessels and the blood flow within them.
Approach:
Aim 1a: Compare SRU-derived measures of renal microvasculature-including microvascular density, tortuosity, and cortical perfusion-between patients who develop DGF and those with uncomplicated graft function.
Aim 1b: Correlate SRU parameters with clinical outcomes at 30 and 90 days post-transplant, as determined from inpatient and outpatient data within the electronic medical record.
Experimental Plan. Allograft SRU will be performed in 20 renal allograft recipient patients up to 14 days after transplant (n=10 with DGF, n=10 without DGF). Patients will be identified and recruited from within UPMC. After injection with Definity, SRU images and measurements will be obtained as described elsewhere in this protocol. Measures are noninvasive, with the transducer applied to the body surface over the allograft. Measurements will be compared between the two groups, and correlations made with eGFR at 30 and 90 days, total days of dialysis, resistive indices, and interstitial fibrosis/tubular atrophy (IFTA) on the standard 3-month protocol biopsy.
Anticipated Results, Potential Pitfalls, and Future Directions. Investigators expect that renal blood volume and microvessel density will be higher in patients with functioning grafts, and that these parameters will be positively correlated with better outcomes, demonstrating that SRU is a promising and noninvasive prognostic tool.
Expected Outcomes and Impact: Investigators anticipate that SRU will identify microvascular densities predictive of DGF, providing a novel, noninvasive biomarker to guide post-transplant management. Successful completion of this aim will establish SRU as a clinically useful tool to reduce reliance on invasive biopsy and improve early allograft evaluation.
Specific Aim 2: Utilize super-resolution ultrasound (SRU) to evaluate early microvascular changes in high-KDPI kidneys up to 14 days after transplantation to predict early graft function.
Rationale: Donor kidneys with a high Kidney Donor Profile Index (KDPI) are often discarded due to their perceived risk of poor function, despite limited physiologic data on their microvascular integrity. Early post-transplant microvascular alterations may serve as critical indicators of graft viability and short-term function.
Hypothesis: Investigators hypothesize that SRU-detected microvascular changes occurring within the first 48 hours after transplantation can predict early transplanted kidney function and distinguish between high- and low-KDPI kidneys.
Experimental Plan:
Investigators will perform SRU imaging within 14 days of transplantation in kidney allograft recipients, using the same SRU parameters described in Aim 1. Investigators will compare SRU-derived measures such as structure, size, characteristics, and blood flow -between two groups: recipients of high-risk kidneys (KDPI >75; n = 10) and recipients of more optimal kidneys (KDPI <35; n = 10). SRU findings will be correlated with key clinical outcomes, including the incidence of delayed graft function (DGF), need for dialysis, measures of kidney function at 30 and 90 day marks, and the degree of scarring of the functional units of the kidney observed on 90-day protocol biopsies.
Anticipated Results, Potential Pitfalls, and Future Directions:
Investigators anticipate that kidneys with higher KDPI values will demonstrate reduced vascular density and perfusion within 48 hours post-transplant, and that these findings will correlate with inferior 30- and 90-day outcomes. If no significant differences or correlations are observed, investigators will reconsider the utility of the 48-hour timepoint in future studies or examine whether recipient-specific factors (e.g., age, hemodynamic status, blood pressure) influence SRU measurements. Findings from this aim will inform whether SRU can serve as an early, noninvasive measurement of transplanted kidney quality and may challenge current allocation practices that exclude high-KDPI kidneys (high-risk of suboptimal functioning kidneys)
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Roderick J Tan, MD, PHD
- Номер телефона: 4126244008
- Электронная почта: tanrj@upmc.edu
Учебное резервное копирование контактов
- Имя: George F Viriya, MD
- Электронная почта: viriyagf@upmc.edu
Места учебы
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Соединенные Штаты, 15213
- University of Pittsburgh Medical Center
-
Контакт:
- Roderick J Tan, MD, PHD
- Номер телефона: 4126244008
- Электронная почта: tanrj@upmc.edu
-
Контакт:
- George F Viriya, MD
- Номер телефона: 9177480056
- Электронная почта: gviriya@gmail.com
-
Младший исследователь:
- Kang Kim, PHD
-
Младший исследователь:
- George F Viriya, MD
-
Главный следователь:
- Roderick J Tan, MD, PHD
-
Младший исследователь:
- Mohit Madken, MD
-
Младший исследователь:
- Jihoon Park, MD, PHD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
For stage 1 of the study:
- We will enroll patients ≥18 years of age
- Patients who received a kidney transplant 2a. Patients requiring dialysis in the first 14 days after transplant 2b. Patients with working allografts not requiring dialysis (control group)
For stage 2 of the study
- We will enroll patients at least 18 years of age or older
- Patients who received a kidney transplant 2a. Patients who received kidney transplants from low KDPI kidneys (KDPI < 35) 2b. Patients who received kidney transplants from high KDPI kidneys (KDPI > 75)
Exclusion Criteria:
- BMI > 40
- Inability to provide informed consent
- Pregnant woman
- Breastfeeding women
- Hypersensitivity to perfluten lipid microsphere and components including polyethylene glycol (PEG)
- Unstable cardiopulmonary condition (acute myocardial infarction, acute coronary artery symptoms, worsening or unstable congestive heart failure, serious ventricular arrhythmias).
- Known history of cardiac shunts
- Patients who have known sickle cell disease or trait
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
High KDPI
Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with High KDPI allografts
|
Super-resolution ultrasound using lipid microsphere contrast
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
|
|
Low KDPI
Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with Low KDPI allografts
|
Super-resolution ultrasound using lipid microsphere contrast
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
|
|
Delayed Graft Function
Adult end stage kidney disease patients who received a recent deceased donor kidney transplant who require renal replacemen therapy within 2 weeks after transplant.
|
Super-resolution ultrasound using lipid microsphere contrast
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
|
|
Non-delayed Graft Function
Adult end stage kidney disease patients who received a recent deceased donor kidney transplant who do not require renal replacemen therapy within 2 weeks after transplant.
|
Super-resolution ultrasound using lipid microsphere contrast
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
Approved drug or biologic being evaluated for a new indication, population, route of administration, or dosage level not specified in the FDA approved labeling for kidney imaging.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Kidney vascularity
Временное ограничение: Less than 30 minutes
|
Assessment of total renal vascularity and measures of perfusion.
Images obtained with the kidney ultrasound will be analyzed for total number of blood vessels and blood perfusion detected in different regions of the kidney.
|
Less than 30 minutes
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Kidney blood vessel tortuosity
Временное ограничение: up to 30 minutes
|
While the total number of blood vessels may differ between subjects, it is also possible that the number of blood vessel branches may be different.
|
up to 30 minutes
|
Соавторы и исследователи
Спонсор
Публикации и полезные ссылки
Общие публикации
- Chen Q, Yu J, Rush BM, Stocker SD, Tan RJ, Kim K. Ultrasound super-resolution imaging provides a noninvasive assessment of renal microvasculature changes during mouse acute kidney injury. Kidney Int. 2020 Aug;98(2):355-365. doi: 10.1016/j.kint.2020.02.011. Epub 2020 Mar 3.
- Cao W, Cui S, Yang L, Wu C, Liu J, Yang F, Liu Y, Bin J, Hou FF. Contrast-Enhanced Ultrasound for Assessing Renal Perfusion Impairment and Predicting Acute Kidney Injury to Chronic Kidney Disease Progression. Antioxid Redox Signal. 2017 Dec 10;27(17):1397-1411. doi: 10.1089/ars.2017.7006. Epub 2017 Aug 22.
- Aubert O, Reese PP, Audry B, Bouatou Y, Raynaud M, Viglietti D, Legendre C, Glotz D, Empana JP, Jouven X, Lefaucheur C, Jacquelinet C, Loupy A. Disparities in Acceptance of Deceased Donor Kidneys Between the United States and France and Estimated Effects of Increased US Acceptance. JAMA Intern Med. 2019 Oct 1;179(10):1365-1374. doi: 10.1001/jamainternmed.2019.2322.
- Steegh FM, Gelens MA, Nieman FH, van Hooff JP, Cleutjens JP, van Suylen RJ, Daemen MJ, van Heurn EL, Christiaans MH, Peutz-Kootstra CJ. Early loss of peritubular capillaries after kidney transplantation. J Am Soc Nephrol. 2011 Jun;22(6):1024-9. doi: 10.1681/ASN.2010050531. Epub 2011 May 12.
- van der Windt DJ, Mehta R, Jorgensen DR, Bou-Samra P, Hariharan S, Randhawa PS, Sood P, Molinari M, Wijkstrom M, Ganoza A, Tevar AD. Donor acute kidney injury and its effect on 1-year post-transplant kidney allograft fibrosis. Clin Transplant. 2020 Feb;34(2):e13770. doi: 10.1111/ctr.13770. Epub 2020 Feb 11.
- Naesens M, Heylen L, Lerut E, Claes K, De Wever L, Claus F, Oyen R, Kuypers D, Evenepoel P, Bammens B, Sprangers B, Meijers B, Pirenne J, Monbaliu D, de Jonge H, Metalidis C, De Vusser K, Vanrenterghem Y. Intrarenal resistive index after renal transplantation. N Engl J Med. 2013 Nov 7;369(19):1797-806. doi: 10.1056/NEJMoa1301064.
- Chen Q, Yu J, Lukashova L, Latoche JD, Zhu J, Lavery L, Verdelis K, Anderson CJ, Kim K. Validation of Ultrasound Super-Resolution Imaging of Vasa Vasorum in Rabbit Atherosclerotic Plaques. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Aug;67(8):1725-1729. doi: 10.1109/TUFFC.2020.2974747. Epub 2020 Feb 18.
- Horbelt M, Lee SY, Mang HE, Knipe NL, Sado Y, Kribben A, Sutton TA. Acute and chronic microvascular alterations in a mouse model of ischemic acute kidney injury. Am J Physiol Renal Physiol. 2007 Sep;293(3):F688-95. doi: 10.1152/ajprenal.00452.2006. Epub 2007 Jul 11.
- Sharma N, Mahajan A, Qazi YA. Marginal kidney transplantation: the road less traveled. Curr Opin Organ Transplant. 2019 Feb;24(1):92-96. doi: 10.1097/MOT.0000000000000603.
- Hall IE, Schroppel B, Doshi MD, Ficek J, Weng FL, Hasz RD, Thiessen-Philbrook H, Reese PP, Parikh CR. Associations of deceased donor kidney injury with kidney discard and function after transplantation. Am J Transplant. 2015 Jun;15(6):1623-31. doi: 10.1111/ajt.13144. Epub 2015 Mar 11.
- Yamamoto T, Tada T, Brodsky SV, Tanaka H, Noiri E, Kajiya F, Goligorsky MS. Intravital videomicroscopy of peritubular capillaries in renal ischemia. Am J Physiol Renal Physiol. 2002 Jun;282(6):F1150-5. doi: 10.1152/ajprenal.00310.2001.
- Molitoris BA. Therapeutic translation in acute kidney injury: the epithelial/endothelial axis. J Clin Invest. 2014 Jun;124(6):2355-63. doi: 10.1172/JCI72269. Epub 2014 Jun 2.
- Wang HK, Chou YH, Yang AH, Chiou SY, Chiou HJ, Wu TH, Loong CC, Chang CY. Evaluation of cortical perfusion in renal transplants: application of quantified power Doppler ultrasonography. Transplant Proc. 2008 Sep;40(7):2330-2. doi: 10.1016/j.transproceed.2008.06.046.
- Jin Y, Yang C, Wu S, Zhou S, Ji Z, Zhu T, He W. A novel simple noninvasive index to predict renal transplant acute rejection by contrast-enhanced ultrasonography. Transplantation. 2015 Mar;99(3):636-41. doi: 10.1097/TP.0000000000000382.
- Schwenger V, Korosoglou G, Hinkel UP, Morath C, Hansen A, Sommerer C, Dikow R, Hardt S, Schmidt J, Kucherer H, Katus HA, Zeier M. Real-time contrast-enhanced sonography of renal transplant recipients predicts chronic allograft nephropathy. Am J Transplant. 2006 Mar;6(3):609-15. doi: 10.1111/j.1600-6143.2005.01224.x.
- Stenberg B, Wilkinson M, Elliott S, Caplan N. The prevalence and significance of renal perfusion defects in early kidney transplants quantified using 3D contrast enhanced ultrasound (CEUS). Eur Radiol. 2017 Nov;27(11):4525-4531. doi: 10.1007/s00330-017-4871-3. Epub 2017 Jun 7.
- Alvarez Rodriguez S, Hevia Palacios V, Sanz Mayayo E, Gomez Dos Santos V, Diez Nicolas V, Sanchez Gallego MD, Lorca Alvaro J, Burgos Revilla FJ. The Usefulness of Contrast-Enhanced Ultrasound in the Assessment of Early Kidney Transplant Function and Complications. Diagnostics (Basel). 2017 Sep 15;7(3):53. doi: 10.3390/diagnostics7030053.
- Miller DL, Dou C, Wiggins RC. Glomerular capillary hemorrhage induced in rats by diagnostic ultrasound with gas-body contrast agent produces intratubular obstruction. Ultrasound Med Biol. 2009 May;35(5):869-77. doi: 10.1016/j.ultrasmedbio.2008.10.015. Epub 2009 Jan 18.
- Miller DL, Dou C, Wiggins RC. Contrast-enhanced diagnostic ultrasound causes renal tissue damage in a porcine model. J Ultrasound Med. 2010 Oct;29(10):1391-401. doi: 10.7863/jum.2010.29.10.1391.
- Jimenez C, de Gracia R, Aguilera A, Alonso S, Cirugeda A, Benito J, Regojo RM, Aguilar R, Warlters A, Gomez R, Largo C, Selgas R. In situ kidney insonation with microbubble contrast agents does not cause renal tissue damage in a porcine model. J Ultrasound Med. 2008 Nov;27(11):1607-15. doi: 10.7863/jum.2008.27.11.1607.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Патологические процессы
- Мужские мочеполовые заболевания
- Заболевания почек
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Хроническое заболевание
- Атрибуты болезни
- Почечная недостаточность
- Патологические состояния, признаки и симптомы
- Почечная недостаточность, хроническая
- Отсроченная функция трансплантата
- Перфторен
- ФС 069
Другие идентификационные номера исследования
- STUDY25100091
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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. .