Kidney TransplantationPhase 1NCT02911714
Contrast-Enhanced Ultrasound for Kidney Transplant
A Phase 1 study testing Lumason Contrast-Enhanced Ultrasound in people with Kidney Transplantation, run by University of Utah at 1 site in United States.
Trial summary
Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in the early detection of kidney transplant complications, such as delayed graft function (DGF) and acute allograft rejection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Lumason Contrast-Enhanced Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Adult living-donor or deceased-donor kidney transplant recipients
Who cannot join
- Subject is Pregnant
- History of non-renal transplant
- Uncontrolled diabetes or hypertension
- Symptomatic or significant pulmonary or cardiovascular disease
- Clinical decision by the treating team to forego the study procedure due to medical/surgical instability
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital
Salt Lake City, Utah, 84132
About this study
Official title: A Pilot Study to Develop Contrast-Enhanced Ultrasound for Kidney Transplant
Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in the early detection of kidney transplant complications, such as delayed graft function (DGF) and acute allograft rejection. The technique uses an intravenous contrast agent to improve organ visualization with standard duplex ultrasound equipment. A number of FDA-approved agents, including Optison, Definity and Lumason are widely used to improve visualization in technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced ultrasound of the liver. The specific aims of this study are to: develop, implement and refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney allograft visualization; determine associations between contrast-enhanced ultrasound and patterns of allograft injury consistent with delayed graft function; and to compare contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from other causes of dysfunction.
Read the detailed description
Kidney transplantation is the preferred treatment for end-stage renal disease (ESRD) given improved quality of life, longer survival and lower costs compared with chronic dialysis. Despite these long-term benefits, the first year post-transplant is a critical period that influences health care costs for transplantation and long-term patient and allograft survival. The two most common complications in the first year are delayed graft function (DGF), which affects nearly 25% of deceased-donor transplants, and acute allograft rejection, which affects nearly 10% of all transplants (deceased and living donor). DGF is most commonly caused by severe ischemia-reperfusion injury at transplantation and is a known risk factor for acute rejection and premature failure. Driven by an ever-growing transplant waiting list and limited organs, efforts to utilize higher-risk kidneys for increasingly higher-risk recipients may further increase these complication rates. While treatments exist for DGF and acute rejection, the current diagnostic paradigm is to obtain a duplex ultrasound (DUS) of the allograft, based on serial changes in serum creatinine, and then proceed to biopsy if there is clinical concern for rejection. Biopsy is the gold standard to differentiate between causes of allograft dysfunction, but the procedure is invasive and typically takes 24 hours or longer for an interpretation. Thus, early detection of these complications using non-invasive diagnostic methods (a major transplant research goal) could reduce our reliance on biopsies and help improve long-term patient and allograft survival.
Researchers in the United States have safely performed contrast-enhanced ultrasounds of the kidney in healthy participants, and radiologists have used ultrasound contrast agents off-label to better visualize organs other than the heart when clinically indicated. In terms of kidney transplants, European data suggest CEUS of the allograft on post-operative day (POD) 7 is superior to DUS for predicting 12-month allograft function, but there are no published studies using CEUS on POD 1 to diagnose DGF or acute rejection.
The pathophysiology of both DGF and acute rejection involve interactions between the microvasculature, parenchymal cells and inflammatory cells, though with differences in timing and within different zones of the kidney itself. A very important feature of CEUS is its capacity to measure microvascular perfusion, whereas DUS can only estimate flow within larger vessels. This potential innovation for assessing the renal macro- and microvasculature may allow for earlier non-invasive detection of DGF and acute rejection. With additional research, it may ultimately be shown that non-invasive CEUS will revolutionize early DGF and acute rejection diagnosis to enable improvement in long-term patient and allograft survival.
- Conditions
- Kidney Transplantation
- Being tested
- Lumason Contrast-Enhanced Ultrasound
- Keywords
- Kidney Transplantation, Delayed Graft Function, Acute Allograft Rejection, Acute Kidney Injury
- Medical subject headings
- Delayed Graft Function, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumason Contrast-Enhanced UltrasoundDrug
Also called Sulfur hexafluoride lipid-type A microspheres
In both arms, we will use Lumason to measure kidney allograft perfusion via contrast-enhanced ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| CEUS and Delayed Graft Function | Experimental | On the first post-operative day after kidney transplantation, recipients enrolled in the study will undergo CEUS using Lumason to quantify microvascular perfusion within the cortical and medullary zones of the kidney allograft for comparison to the concentration of neutrophil gelatinase-associated lipocalin (NGAL, an early biomarker of acute kidney injury) measured from recipient urine simultaneously collected on the first post-operative day. Receives: Drug: Lumason Contrast-Enhanced Ultrasound |
| CEUS and Biopsy-Proven Acute Rejection | Experimental | We will identify and enroll kidney transplant recipients in need of clinically-indicated duplex ultrasounds and possible biopsy to evaluate allograft dysfunction during hospital admissions and outpatient follow-up. Immediately after the duplex ultrasound, we will perform CEUS using Lumason for allograft perfusion measurements to determine its potential association with biopsy-proven acute rejection according to the most recent Banff criteria. Receives: Drug: Lumason Contrast-Enhanced Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker-Defined Delayed Graft Function
A meta-analysis of 19 studies found urine neutrophil gelatinase-associated lipocalin (NGAL) >150 ng/mL (within hours of the inciting event) had an area under the receiver-operating characteristic curve (AUC) of 0.815 for identifying acute kidney injury (defined as an ensuing rise in serum creatinine by ≥50%). We noted an AUC of 0.82 for predicting the need for dialysis in the first week (i.e., dialysis-defined delayed graft function) with an optimal urine NGAL cutoff of >350 ng/mL. For this study outcome, we will determine the Spearman correlation between CEUS-assessed allograft perfusion and degree of allograft injury based on post-operative day 1 urine NGAL concentration.
Measured: Post-Operative Day 1
Biopsy-Proven Acute Rejection
The Banff (2013) classification of acute kidney allograft rejection requires histologic evidence of acute tissue injury, evidence of recent antibody interaction with renal vascular endothelium, and serologic evidence of donor-specific antibodies in order to diagnose acute antibody-mediate rejection. Acute T-cell mediated rejection is histologically graded by the extent of interstitial inflammation and vascular involvement.
Measured: Any Time After Kidney Transplantation
Secondary outcomes (1)
Dialysis-Defined Delayed Graft Function
The need for any dialysis in the first week of transplant.
Measured: First Post-Operative Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start21 Feb 2018
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, United States, American Heart Association, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Isaac E Hall, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911714
- Sponsor's protocol ID
- IRB_00092223
- Other IDs
- KL2TR002539
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2016
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Develop Contrast-Enhanced Ultrasound for Kidney Transplant
- ClinicalTrials.gov ID
- NCT02911714
- Acronym / sponsor ID
- IRB_00092223
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplantation, Delayed Graft Function, Acute Allograft Rejection, Acute Kidney Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of funding
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Kidney Foundation, United States, American Heart Association, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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.
Contrast-enhanced ultrasound (CEUS) is a promising non-invasive imaging tool that may aid in the early detection of kidney transplant complications, such as delayed graft function (DGF) and acute allograft rejection. The technique uses an intravenous contrast agent to improve organ visualization with standard duplex ultrasound equipment. A number of FDA-approved agents, including Optison, Definity and Lumason are widely used to improve visualization in technically limited echocardiograms, and Lumason was recently approved for contrast-enhanced ultrasound of the liver. The specific aims of this study are to: develop, implement and refine a contrast-enhanced ultrasound protocol using Lumason to safely maximize kidney allograft visualization; determine associations between contrast-enhanced ultrasound and patterns of allograft injury consistent with delayed graft function; and to compare contrast-enhanced ultrasound with duplex ultrasound for differentiating acute rejection from other causes of dysfunction.
Detailed description
Kidney transplantation is the preferred treatment for end-stage renal disease (ESRD) given improved quality of life, longer survival and lower costs compared with chronic dialysis. Despite these long-term benefits, the first year post-transplant is a critical period that influences health care costs for transplantation and long-term patient and allograft survival. The two most common complications in the first year are delayed graft function (DGF), which affects nearly 25% of deceased-donor transplants, and acute allograft rejection, which affects nearly 10% of all transplants (deceased and living donor). DGF is most commonly caused by severe ischemia-reperfusion injury at transplantation and is a known risk factor for acute rejection and premature failure. Driven by an ever-growing transplant waiting list and limited organs, efforts to utilize higher-risk kidneys for increasingly higher-risk recipients may further increase these complication rates. While treatments exist for DGF and acute rejection, the current diagnostic paradigm is to obtain a duplex ultrasound (DUS) of the allograft, based on serial changes in serum creatinine, and then proceed to biopsy if there is clinical concern for rejection. Biopsy is the gold standard to differentiate between causes of allograft dysfunction, but the procedure is invasive and typically takes 24 hours or longer for an interpretation. Thus, early detection of these complications using non-invasive diagnostic methods (a major transplant research goal) could reduce our reliance on biopsies and help improve long-term patient and allograft survival.
Researchers in the United States have safely performed contrast-enhanced ultrasounds of the kidney in healthy participants, and radiologists have used ultrasound contrast agents off-label to better visualize organs other than the heart when clinically indicated. In terms of kidney transplants, European data suggest CEUS of the allograft on post-operative day (POD) 7 is superior to DUS for predicting 12-month allograft function, but there are no published studies using CEUS on POD 1 to diagnose DGF or acute rejection.
The pathophysiology of both DGF and acute rejection involve interactions between the microvasculature, parenchymal cells and inflammatory cells, though with differences in timing and within different zones of the kidney itself. A very important feature of CEUS is its capacity to measure microvascular perfusion, whereas DUS can only estimate flow within larger vessels. This potential innovation for assessing the renal macro- and microvasculature may allow for earlier non-invasive detection of DGF and acute rejection. With additional research, it may ultimately be shown that non-invasive CEUS will revolutionize early DGF and acute rejection diagnosis to enable improvement in long-term patient and allograft survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEUS and Delayed Graft Function | Experimental | Drug: Lumason Contrast-Enhanced UltrasoundOn the first post-operative day after kidney transplantation, recipients enrolled in the study will undergo CEUS using Lumason to quantify microvascular perfusion within the cortical and medullary zones of the kidney allograft for comparison to the concentration of neutrophil gelatinase-associated lipocalin (NGAL, an early biomarker of acute kidney injury) measured from recipient urine simultaneously collected on the first post-operative day. |
| CEUS and Biopsy-Proven Acute Rejection | Experimental | Drug: Lumason Contrast-Enhanced UltrasoundWe will identify and enroll kidney transplant recipients in need of clinically-indicated duplex ultrasounds and possible biopsy to evaluate allograft dysfunction during hospital admissions and outpatient follow-up. Immediately after the duplex ultrasound, we will perform CEUS using Lumason for allograft perfusion measurements to determine its potential association with biopsy-proven acute rejection according to the most recent Banff criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult living-donor or deceased-donor kidney transplant recipients
Key exclusion criteria (5 listed)
- Subject is Pregnant
- History of non-renal transplant
- Uncontrolled diabetes or hypertension
- Symptomatic or significant pulmonary or cardiovascular disease
- Clinical decision by the treating team to forego the study procedure due to medical/surgical instability
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 |
|---|---|---|
| Lumason Contrast-Enhanced UltrasoundAlso: Sulfur hexafluoride lipid-type A microspheresIn both arms, we will use Lumason to measure kidney allograft perfusion via contrast-enhanced ultrasound. | Drug | CEUS and Biopsy-Proven Acute Rejection, CEUS and Delayed Graft Function |
Primary outcome
Biomarker-Defined Delayed Graft Function
Time frame: Post-Operative Day 1
A meta-analysis of 19 studies found urine neutrophil gelatinase-associated lipocalin (NGAL) >150 ng/mL (within hours of the inciting event) had an area under the receiver-operating characteristic curve (AUC) of 0.815 for identifying acute kidney injury (defined as an ensuing rise in serum creatinine by ≥50%). We noted an AUC of 0.82 for predicting the need for dialysis in the first week (i.e., dialysis-defined delayed graft function) with an optimal urine NGAL cutoff of >350 ng/mL. For this study outcome, we will determine the Spearman correlation between CEUS-assessed allograft perfusion and degree of allograft injury based on post-operative day 1 urine NGAL concentration.
Biopsy-Proven Acute Rejection
Time frame: Any Time After Kidney Transplantation
The Banff (2013) classification of acute kidney allograft rejection requires histologic evidence of acute tissue injury, evidence of recent antibody interaction with renal vascular endothelium, and serologic evidence of donor-specific antibodies in order to diagnose acute antibody-mediate rejection. Acute T-cell mediated rejection is histologically graded by the extent of interstitial inflammation and vascular involvement.
1 secondary outcome
Dialysis-Defined Delayed Graft Function
Time frame: First Post-Operative Week
Results and safety
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Isaac E Hall, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lumason Contrast-Enhanced Ultrasound in people with Kidney Transplantation, run by University of Utah 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 24 Dec 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker-Defined Delayed Graft Function (time frame: Post-Operative Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.