End Stage Chronic Renal FailureMUST-DNCT07645599
Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function
An observational study of End Stage Chronic Renal Failure and Renal Transplant, run by Roderick Tan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Chronic Renal Failure, Renal Transplant, Microvascular Changes
- What is being tested?
- Ultrasound contrast agent (Contrast-enhanced ultrasound), Optison (Perflutren Protein-Type A Microspheres Injectable Suspension) and Lumason® contrast agent
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 30 Jun 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with end stage kidney disease who are receiving deceased donor kidney allograft transplants who meet the inclusion and exclusion criteria
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
George F Viriya, MD contact
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
George F Viriya, MD, 9177480056, gviriya@gmail.com
Roderick J Tan, MD, PHD, 4126244008, tanrj@upmc.edu
About this study
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.
Read the detailed description
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)
- Conditions
- End Stage Chronic Renal Failure, Renal Transplant, Microvascular Changes, Microvascular Circulation
- Being tested
- Ultrasound contrast agent (Contrast-enhanced ultrasound), Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Lumason® contrast agent, DEFINITY®
- Keywords
- renal allograft, kidney allograft, kidney transplant, super-resolution ultrasound, lipid microspheres, renal microvasculature, kidney microvasculature, delayed graft function, Kidney Donor Profile Index, deceased donor kidney transplant
- Medical subject headings
- Renal Insufficiency, Chronic, Delayed Graft Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound contrast agent (Contrast-enhanced ultrasound)Diagnostic test
Super-resolution ultrasound using lipid microsphere contrast
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)Drug
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.
Lumason® contrast agentDrug
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.
DEFINITY®Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| High KDPI | Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with High KDPI allografts Receives: Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound); Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Lumason® contrast agent; Drug: DEFINITY® | |
| Low KDPI | Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with Low KDPI allografts Receives: Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound); Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Lumason® contrast agent; Drug: DEFINITY® | |
| 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. Receives: Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound); Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Lumason® contrast agent; Drug: DEFINITY® | |
| 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. Receives: Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound); Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension); Drug: Lumason® contrast agent; Drug: DEFINITY® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney vascularity
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.
Measured: Less than 30 minutes
Secondary outcomes (1)
Kidney blood vessel tortuosity
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.
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for End Stage Chronic Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Roderick Tan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roderick Tan, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645599
- Sponsor's protocol ID
- STUDY25100091
- Acronym
- MUST-D
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Patient data such as demographics, test results, medical chart data, and data acquired from imaging including vessel density, cortical perfusion, and vessel branching.
Publications
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.
PubMed 21566051Aubert 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.
PubMed 31449299van 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.
PubMed 31829462Naesens 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.
PubMed 24195547Chen 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.
PubMed 32086204Horbelt 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.
PubMed 17626153Sharma 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.
PubMed 30507708Hall 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.
PubMed 25762442Yamamoto 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.
PubMed 11997332Molitoris 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.
PubMed 24892710Cao 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.
PubMed 28715949Wang 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.
PubMed 18790226Jin 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.
PubMed 25119133Schwenger 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.
PubMed 16468973Stenberg 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.
PubMed 28593430
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvasculature Ultrasound Super-resolution in Transplant Delayed Graft Function
- ClinicalTrials.gov ID
- NCT07645599
- Acronym / sponsor ID
- MUST-D / STUDY25100091
- Conditions
- End Stage Chronic Renal Failure, Renal Transplant, Microvascular Changes, Microvascular Circulation
- Keywords
- renal allograft, kidney allograft, kidney transplant, super-resolution ultrasound, lipid microspheres, renal microvasculature, kidney microvasculature, delayed graft function
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Roderick TanUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High KDPI | – | Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound), Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Drug: Lumason® contrast agent, Drug: DEFINITY®Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with High KDPI allografts |
| Low KDPI | – | Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound), Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Drug: Lumason® contrast agent, Drug: DEFINITY®Adult end stage kidney disease patients who received a recent deceased donor kidney transplant with Low KDPI allografts |
| Delayed Graft Function | – | Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound), Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Drug: Lumason® contrast agent, Drug: DEFINITY®Adult end stage kidney disease patients who received a recent deceased donor kidney transplant who require renal replacemen therapy within 2 weeks after transplant. |
| Non-delayed Graft Function | – | Diagnostic Test: Ultrasound contrast agent (Contrast-enhanced ultrasound), Drug: Optison (Perflutren Protein-Type A Microspheres Injectable Suspension), Drug: Lumason® contrast agent, Drug: DEFINITY®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with end stage kidney disease who are receiving deceased donor kidney allograft transplants who meet the inclusion and exclusion criteria
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (8 listed)
- BMI > 40
- Inability to provide informed consent
- Pregnant woman
- Breastfeeding women
- Hypersensitivity to perfluten lipid microsphere and components including polyethylene glycol (PEG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound contrast agent (Contrast-enhanced ultrasound)Super-resolution ultrasound using lipid microsphere contrast | Diagnostic test | Delayed Graft Function, High KDPI, Low KDPI, Non-delayed Graft Function |
| Optison (Perflutren Protein-Type A Microspheres Injectable Suspension)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. | Drug | Delayed Graft Function, High KDPI, Low KDPI, Non-delayed Graft Function |
| Lumason® contrast agentApproved 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. | Drug | Delayed Graft Function, High KDPI, Low KDPI, Non-delayed Graft Function |
| DEFINITY®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. | Drug | Delayed Graft Function, High KDPI, Low KDPI, Non-delayed Graft Function |
Primary outcome
Kidney vascularity
Time frame: 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.
1 secondary outcome
Kidney blood vessel tortuosity
Time frame: up to 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 21566051Steegh 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.
- Background: PubMed 31449299Aubert 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.
- Background: PubMed 31829462van 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.
- Background: PubMed 24195547Naesens 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.
- Background: PubMed 32086204Chen 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.
- Background: PubMed 17626153Horbelt 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.
- Background: PubMed 30507708Sharma 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.
- Background: PubMed 25762442Hall 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.
- Background: PubMed 11997332Yamamoto 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.
- Background: PubMed 24892710Molitoris 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.
- Background: PubMed 28715949Cao 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.
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- Individual participant dataSharing planned: Yes. Patient data such as demographics, test results, medical chart data, and data acquired from imaging including vessel density, cortical perfusion, and vessel branching.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
George F Viriya, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Chronic Renal Failure and Renal Transplant, run by Roderick Tan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roderick J Tan, MD, PHD (4126244008, Tanrj@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney vascularity (time frame: Less than 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07645599, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.