Renal Transplant RejectionPhase 2NCT02733029
Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection
A Phase 2 study testing Sonazoid and contrast enhanced ultrasonography in people with Renal Transplant Rejection, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and efficacy of detecting kidney transplant rejection using contrast enhance ultrasonography with the contrast agent Sonazoid. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- Sonazoid and contrast enhanced ultrasonography
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 1 Feb 2023
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (ages 18-75) who have undergone renal transplant at the Brigham and Women's Hospital. [For stage 1 or stage 2]
- Experiencing acute and chronic renal allograft rejection - defined by by examining the histological sections of renal transplant biopsy for a renal pathologist. This is the most accurate way to evaluate the presence of absence of acute and chronic renal transplant biopsy. [For stage 2]
- Adults (ages 18-75) who have undergone renal transplant at the Brigham and Women's Hospital with normal serum creatinine values (~1 mg/dl) [For stage 2 medical record review only]
Who cannot join
- Hemodynamic instability (e.g., blood pressure < 90)
- Atrial fibrillation with rapid ventricular response
- Arrhythmia
- Poor acoustic windows
- Inability to provide informed consent
- Known right to left or bidirectional cardiac shunts
- Any contraindication such as the history of allergic reactions
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to determine the feasibility and efficacy of detecting kidney transplant rejection using contrast enhance ultrasonography with the contrast agent Sonazoid.
Read the detailed description
This study will be divided into two stages. In the first stage the investigators will assess the transplant kidney with ultrasound after contrast injection (Sonazoid) to determine if contrast in the kidney is detectable by ultrasound and to determine if the amount of perfusion can be quantified directly or qualitatively. The investigators aim to have one to two subjects in this stage. If perfusion of the kidney can be assessed, then the investigators will move to stage two of the study.
In stage 2, the investigators will look to determine the ability of the contrast enhanced ultrasonography method to detect renal transplant rejection using Sonazoid. For this stage the investigators will recruit subjects with biopsy confirmed renal transplant rejection. Once subjects are consented, they will undergo contrast enhanced ultrasonography with Sonazoid and have images taken. These images will be compared to images of renal transplant patients that have displayed no rejection or clinical issues. These clinically normal subjects will have previously consented to a medical record review so that the investigators may use their images.
- Conditions
- Renal Transplant Rejection
- Being tested
- Sonazoid, contrast enhanced ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonazoidDrug
Sonazoid (GE Healthcare) is a contrast agent that is a lipid-stabilized suspension of perfluorobutane microbubbles
contrast enhanced ultrasonographyDevice
Injection of intravenous ultrasound contrast
| Study group | Role | What they receive |
|---|---|---|
| Sonazoid contrast | Experimental | The contrast agent Sonazoid will be used during contrast enhanced ultrasonography. This will be a one-time administration of the contrast agent. The contrast agent, Sonazoid (GE Healthcare), is a lipid-stabilized suspension of perfluorobutane microbubbles with a median diameter of 2.4-3.5 μm and will be administered per package insert (intravenously as a continuous infusion). Sonazoid contrast agent will be given at a dose 0.0075 mL/Kg as a bolus intravenous injection while visualizing the kidney transplant. Receives: Drug: Sonazoid; Device: contrast enhanced ultrasonography |
| Medical Review | No intervention | Ultrasound imaging will be taken from a group of subjects recruited for stage 2. These will be obtained through medical record review from subjects with successful renal transplant at BWH and no transplant rejection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indication of acute renal allograft rejection that has been confirmed by biopsy
Measured: Through completion of study, an average of 2 years
Secondary outcomes (1)
Indication of chronic renal allograft rejection (CAN) that has been confirmed by biopsy
Measured: Through completion of study, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start30 May 2018
- Primary completion30 May 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Andrew Michael Siedlecki, Brigham and Women's Hospital
- Investigators
- Reza Abdi, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733029
- Sponsor's protocol ID
- 2016P000574
- Status last verified
- Mar 2023
- First submitted
- 18 Mar 2016
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jeetley P, Hickman M, Kamp O, Lang RM, Thomas JD, Vannan MA, Vanoverschelde JL, van der Wouw PA, Senior R. Myocardial contrast echocardiography for the detection of coronary artery stenosis: a prospective multicenter study in comparison with single-photon emission computed tomography. J Am Coll Cardiol. 2006 Jan 3;47(1):141-5. doi: 10.1016/j.jacc.2005.08.054. Epub 2005 Dec 15.
PubMed 16386678Tsuruoka K, Yasuda T, Koitabashi K, Yazawa M, Shimazaki M, Sakurada T, Shirai S, Shibagaki Y, Kimura K, Tsujimoto F. Evaluation of renal microcirculation by contrast-enhanced ultrasound with Sonazoid as a contrast agent. Int Heart J. 2010 May;51(3):176-82. doi: 10.1536/ihj.51.176.
PubMed 20558907Siedlecki AM, Benson C, Frates M, Azzi J, Hoffman RJ, Milford E, Weins A, Chandraker A, Mc Donald N, Philip White J, Abdi R. First Report of Perfluorobutane Microsphere-Enhanced Ultrasound in the Transplant Kidney. Transplantation. 2019 Oct;103(10):e283-e284. doi: 10.1097/TP.0000000000002856. No abstract available.
PubMed 31335773
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection
- ClinicalTrials.gov ID
- NCT02733029
- Acronym / sponsor ID
- 2016P000574
- Conditions
- Renal Transplant Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 30 May 2018 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 11 Apr 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.
The purpose of this study is to determine the feasibility and efficacy of detecting kidney transplant rejection using contrast enhance ultrasonography with the contrast agent Sonazoid.
Detailed description
This study will be divided into two stages. In the first stage the investigators will assess the transplant kidney with ultrasound after contrast injection (Sonazoid) to determine if contrast in the kidney is detectable by ultrasound and to determine if the amount of perfusion can be quantified directly or qualitatively. The investigators aim to have one to two subjects in this stage. If perfusion of the kidney can be assessed, then the investigators will move to stage two of the study.
In stage 2, the investigators will look to determine the ability of the contrast enhanced ultrasonography method to detect renal transplant rejection using Sonazoid. For this stage the investigators will recruit subjects with biopsy confirmed renal transplant rejection. Once subjects are consented, they will undergo contrast enhanced ultrasonography with Sonazoid and have images taken. These images will be compared to images of renal transplant patients that have displayed no rejection or clinical issues. These clinically normal subjects will have previously consented to a medical record review so that the investigators may use their images.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonazoid contrast | Experimental | Drug: Sonazoid, Device: contrast enhanced ultrasonographyThe contrast agent Sonazoid will be used during contrast enhanced ultrasonography. This will be a one-time administration of the contrast agent. The contrast agent, Sonazoid (GE Healthcare), is a lipid-stabilized suspension of perfluorobutane microbubbles with a median diameter of 2.4-3.5 μm and will be administered per package insert (intravenously as a continuous infusion). Sonazoid contrast agent will be given at a dose 0.0075 mL/Kg as a bolus intravenous injection while visualizing the kidney transplant. |
| Medical Review | No intervention | –Ultrasound imaging will be taken from a group of subjects recruited for stage 2. These will be obtained through medical record review from subjects with successful renal transplant at BWH and no transplant rejection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (ages 18-75) who have undergone renal transplant at the Brigham and Women's Hospital. [For stage 1 or stage 2]
- Experiencing acute and chronic renal allograft rejection - defined by by examining the histological sections of renal transplant biopsy for a renal pathologist. This is the most accurate way to evaluate the presence of absence of acute and chronic renal transplant biopsy. [For stage 2]
- Adults (ages 18-75) who have undergone renal transplant at the Brigham and Women's Hospital with normal serum creatinine values (~1 mg/dl) [For stage 2 medical record review only]
Key exclusion criteria (8 listed)
- Hemodynamic instability (e.g., blood pressure < 90)
- Atrial fibrillation with rapid ventricular response
- Arrhythmia
- Poor acoustic windows
- Inability to provide informed consent
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 |
|---|---|---|
| SonazoidSonazoid (GE Healthcare) is a contrast agent that is a lipid-stabilized suspension of perfluorobutane microbubbles | Drug | Sonazoid contrast |
| contrast enhanced ultrasonographyInjection of intravenous ultrasound contrast | Device | Sonazoid contrast |
Primary outcome
Indication of acute renal allograft rejection that has been confirmed by biopsy
Time frame: Through completion of study, an average of 2 years
1 secondary outcome
Indication of chronic renal allograft rejection (CAN) that has been confirmed by biopsy
Time frame: Through completion of study, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Background: PubMed 16386678Jeetley P, Hickman M, Kamp O, Lang RM, Thomas JD, Vannan MA, Vanoverschelde JL, van der Wouw PA, Senior R. Myocardial contrast echocardiography for the detection of coronary artery stenosis: a prospective multicenter study in comparison with single-photon emission computed tomography. J Am Coll Cardiol. 2006 Jan 3;47(1):141-5. doi: 10.1016/j.jacc.2005.08.054. Epub 2005 Dec 15.
- Background: PubMed 20558907Tsuruoka K, Yasuda T, Koitabashi K, Yazawa M, Shimazaki M, Sakurada T, Shirai S, Shibagaki Y, Kimura K, Tsujimoto F. Evaluation of renal microcirculation by contrast-enhanced ultrasound with Sonazoid as a contrast agent. Int Heart J. 2010 May;51(3):176-82. doi: 10.1536/ihj.51.176.
- Derived from this study: PubMed 31335773Siedlecki AM, Benson C, Frates M, Azzi J, Hoffman RJ, Milford E, Weins A, Chandraker A, Mc Donald N, Philip White J, Abdi R. First Report of Perfluorobutane Microsphere-Enhanced Ultrasound in the Transplant Kidney. Transplantation. 2019 Oct;103(10):e283-e284. doi: 10.1097/TP.0000000000002856. No abstract available.
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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.
Reza Abdi, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sonazoid and contrast enhanced ultrasonography in people with Renal Transplant Rejection, run by Brigham and Women's Hospital 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 3 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: finished, as of the sponsor's last update on 6 Mar 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Indication of acute renal allograft rejection that has been confirmed by biopsy (time frame: Through completion of study, an average of 2 years). 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 NCT02733029, which also lists 3 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 6 Mar 2023.