Kidney Transplant RejectionNCT03304223
IL2 Imaging in Renal Transplantation
A study testing [18F]FB-IL2 PET scan in people with Kidney Transplant Rejection, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- [18F]FB-IL2 PET scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2017to 1 Dec 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male aged between 18 and 80 years.
- Renal Transplant recipients
- The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.
- All patients will have a clinical indication for renal biopsy.
Who cannot join
- Patients with multiple-organ transplants.
- Female patients who are pregnant or unwilling to use adequate contraception during the study.
- Claustrophobia
- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- A clinical reason for an immediate start of a therapeutic intervention with immunosuppressive medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof of Concept Study for [18F]FB-IL2 PET Imaging of Infiltrating T Cells After Renal Transplantation; a Diagnostic Tool for Acute Rejection
After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection. However, this is an intervention associated with complications like bleeding, patient discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false negative results. So, the introduction of a new non-invasive diagnostic tool for allograft rejection could have major implications for the care of renal transplant recipients. For the purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET), the tracer 18-Fluor-Interleukin-2 ([18F]FB-IL2) has been developed. The investigators hypothesized that a high correlation exists between [18F]FB-IL2 uptake and the extend of T cell infiltration into renal transplants with signs of rejection
- Conditions
- Kidney Transplant Rejection
- Being tested
- [18F]FB-IL2 PET scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FB-IL2 PET scanDiagnostic test
[18F]FB-IL2 PET scan procedure
| Study group | Role | What they receive |
|---|---|---|
| [18F]FB-IL2 PET scan | Experimental | Renal transplant recipients with a clinical suspicion for renal transplant rejection. Receives: Diagnostic Test: [18F]FB-IL2 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of the [18F]FB-IL2 PET to detect renal transplant rejection
Uptake of [18F]FB-IL2 in the renal transplant will be correlated to inflammatory infiltrate and histological BANFF score.
Measured: At study day 2, when PET procedure is performed.
Secondary outcomes (2)
Uptake of [18F]FB-IL2 and correlation with renal function
Uptake of [18F]FB-IL2 in the renal transplant will be correlated to renal function as measured by 24-hours urine clearance and the Modification of Diet in Renal Disease equation (MDRD).
Measured: At study day 2, when PET procedure is performed.
Uptake of [18F]FB-IL2 and correlation with T-cell subpopulations
Uptake of [18F]FB-IL2 in the renal transplant will be correlated to T-cell subpopulations in urine and blood.
Measured: At study day 2, when PET procedure is performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start1 Dec 2017
- Primary completion1 Dec 2022
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.S.F. Sanders, University Medical Center Groningen
- Investigators
- Jan-Stephan F Sanders, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304223
- Sponsor's protocol ID
- 201501004
- Status last verified
- May 2023
- First submitted
- 22 Sep 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study for [18F]FB-IL2 PET Imaging of Infiltrating T Cells After Renal Transplantation; a Diagnostic Tool for Acute Rejection
- ClinicalTrials.gov ID
- NCT03304223
- Acronym / sponsor ID
- 201501004
- Conditions
- Kidney Transplant Rejection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 6 Oct 2017 (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.
After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection. However, this is an intervention associated with complications like bleeding, patient discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false negative results. So, the introduction of a new non-invasive diagnostic tool for allograft rejection could have major implications for the care of renal transplant recipients. For the purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET), the tracer 18-Fluor-Interleukin-2 ([18F]FB-IL2) has been developed. The investigators hypothesized that a high correlation exists between [18F]FB-IL2 uptake and the extend of T cell infiltration into renal transplants with signs of rejection
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FB-IL2 PET scan | Experimental | Diagnostic Test: [18F]FB-IL2 PET scanRenal transplant recipients with a clinical suspicion for renal transplant rejection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female or male aged between 18 and 80 years.
- Renal Transplant recipients
- The patient understands the purpose and risks of the study and has given written informed consent to participate in the study.
- All patients will have a clinical indication for renal biopsy.
Key exclusion criteria (5 listed)
- Patients with multiple-organ transplants.
- Female patients who are pregnant or unwilling to use adequate contraception during the study.
- Claustrophobia
- Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- A clinical reason for an immediate start of a therapeutic intervention with immunosuppressive medication.
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 |
|---|---|---|
| [18F]FB-IL2 PET scan[18F]FB-IL2 PET scan procedure | Diagnostic test | [18F]FB-IL2 PET scan |
Primary outcome
The ability of the [18F]FB-IL2 PET to detect renal transplant rejection
Time frame: At study day 2, when PET procedure is performed.
Uptake of [18F]FB-IL2 in the renal transplant will be correlated to inflammatory infiltrate and histological BANFF score.
2 secondary outcomes
Uptake of [18F]FB-IL2 and correlation with renal function
Time frame: At study day 2, when PET procedure is performed.
Uptake of [18F]FB-IL2 and correlation with T-cell subpopulations
Time frame: At study day 2, when PET procedure is performed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jan-Stephan F Sanders, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]FB-IL2 PET scan in people with Kidney Transplant Rejection, run by University Medical Center Groningen at 1 site in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 11 May 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 Netherlands. 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?
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?
The ability of the [18F]FB-IL2 PET to detect renal transplant rejection (time frame: At study day 2, when PET procedure is performed.). 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 11 May 2023.