Kidney Graft FibrosisNCT05638308
FAZA PETMRI Kidney Graft Fibrosis Study
A study testing FAZA PET/MRI scan in people with Kidney Graft Fibrosis, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Fibrosis is the final common pathway of solid organ diseases and accounts for ~45% of deaths in the developed world. Fibrosis is characterized by excessive deposition of extracellular matrix that replaces normal organ parenchyma, leading to loss of function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Graft Fibrosis
- What is being tested?
- FAZA PET/MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 26 May 2018to 13 Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Evidence of impaired kidney graft function based on elevated serum creatinine from baseline and/ or evidence of significant proteinuria and/or donor specific antibodies
- A negative urine or serum pregnancy test within the three week interval immediately prior to imaging, in women of child-bearing age
- Ability to provide written informed consent to participate in the study (for both patients groups - with and without impaired kidney graft function)
- Two study groups:
- Evidence of impaired kidney graft function based on elevated serum creatinine from baseline and/ or evidence of significant proteinuria and/or donor specific antibodies and scheduled for a kidney graft biopsy.
- comparison (control) group with stable kidney graft function, matched for graft/recipient age, sex and comorbidities
Who cannot join
- Contraindication for MR as per current institutional guidelines
- Inability to lie supine for at least 30 minutes
- Any patient who is pregnant or breastfeeding
- Any patient unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Diagnostic Performance and Prognostic Value of 18F-Fluoroazomycin Arabinoside (FAZA) Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR) in Patients With Kidney Graft Fibrosis
Fibrosis is the final common pathway of solid organ diseases and accounts for ~45% of deaths in the developed world. Fibrosis is characterized by excessive deposition of extracellular matrix that replaces normal organ parenchyma, leading to loss of function. Chronic kidney disease is invariably characterized by fibrosis and affects >3 million Canadians. Although fibrosis can affect all compartments in the kidney. Interstitial fibrosis/tubular atrophy (IFTA) is the most potent predictor of kidney disease progression, regardless of its underlying cause. In addition to affecting native kidneys, IFTA also occurs in kidney allografts in transplanted patients, resulting in progressive kidney allograft dysfunction and, finally allograft loss with significant implications for patients' care and also financial implications for the healthcare system. However, early, noninvasive markers of IFTA or ongoing hypoxia in the kidney grafts are lacking. This is particularly problematic, since diagnosis of IFTA is often made late in the course of disease, and once IFTA develops, it is generally considered irreversible. There is thus an unmet clinical need to identify early markers of IFTA that could guide the use of novel anti-fibrotic therapies.
In patients with clinically decreasing allograft function or protienuria, indication (or for cause) biopsies are the gold standard test used to identify the cause for the functional decrease. However, biopsies carry significant procedural risk (e.g. bleeding and death) and suffer from a sampling bias - not all areas of the kidneys are accessible for biopsy and there is currently no way to target the fibrotic / hypoxic areas. Urine protein measurements are obviously also not suitable to resolve this clinical dilemma. There would thus be great clinical interest in developing non-invasive tools that could provide more information compared to traditional tests for monitoring renal hypoxia and injury through imaging and urinary biomarkers.
Read more
Our aims would be to image patients with different states of allograft function impairment and ideally find an imaging-based way to monitor those patients after transplantation. This way, an early detection of evolving interstitial fibrosis/tubular atrophy (IFTA) might be possible in a non-invasive way.The goal of this trial is to validate FAZA-PET/MR as a biomarker of hypoxia by correlating its uptake in patients with kidney allograft fibrosis with mass spectrometry based quantitative assays for monitoring of fibrotic markers in the urine of those same patients.
There would thus be great clinical interest in developing non-invasive tools that could provide more information compared to traditional tests for monitoring renal hypoxia and injury through imaging and urinary biomarkers. Whereas currently only allograft biopsy can be performed to detect (rather late stage) interstitial fibrosis/ tubular atrophy.
The study subjects' clinical management will not be changed based on the PET-MR scan within the trial.
- Conditions
- Kidney Graft Fibrosis
- Being tested
- FAZA PET/MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAZA PET/MRI scanDiagnostic test
FAZA PET/MRI scan before the standard of care biopsy for case group
| Study group | Role | What they receive |
|---|---|---|
| FAZA PET/MRI scan | Other | FAZA PET/MRI scan before the standard of care biopsy for case group Receives: Diagnostic Test: FAZA PET/MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To image patients with different states of allograft function impairment and ideally find an imaging-based way to monitor those patients after transplantation
The FAZA uptake during the PET/MRI scan
Measured: Before the planned routine biopsy procedure for case patients
To image patients with different states of allograft function impairment and ideally find an imaging-based way to monitor those patients after transplantation
The FAZA uptake during the PET/MRI scan
Measured: Through study completion once patient with stable graft function and minimal or no fibrosis on time zero biopsy and age matched graft age is identified. Up to 60 months
Secondary outcomes (2)
Performing urine assays whereby AngII activity proteins in urine to predict the survival/viability outcome of the kidney allograft
Evaluate AngII-regulated proteins in urine samples
Measured: Before the planned routine biopsy procedure for case patients
Performing urine assays whereby AngII activity proteins in urine to predict the survival/viability outcome of the kidney allograft
Evaluate AngII-regulated proteins in urine samples
Measured: Through study completion once patient with stable graft function and minimal or no fibrosis on time zero biopsy and age matched graft age is identified. Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start26 May 2018
- Primary completion13 Jun 2023
- Study completion13 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Graft FibrosisStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- FAZA PET/MRI Scan
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Veit-Haibach, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638308
- Sponsor's protocol ID
- 17-5695
- Status last verified
- Apr 2024
- First submitted
- 25 Nov 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Performance and Prognostic Value of 18F-Fluoroazomycin Arabinoside (FAZA) Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR) in Patients With Kidney Graft Fibrosis
- ClinicalTrials.gov ID
- NCT05638308
- Acronym / sponsor ID
- 17-5695
- Conditions
- Kidney Graft Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 26 May 2018 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 Jun 2023 (actual)
- First posted
- 6 Dec 2022 (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.
Fibrosis is the final common pathway of solid organ diseases and accounts for ~45% of deaths in the developed world. Fibrosis is characterized by excessive deposition of extracellular matrix that replaces normal organ parenchyma, leading to loss of function. Chronic kidney disease is invariably characterized by fibrosis and affects >3 million Canadians. Although fibrosis can affect all compartments in the kidney. Interstitial fibrosis/tubular atrophy (IFTA) is the most potent predictor of kidney disease progression, regardless of its underlying cause. In addition to affecting native kidneys, IFTA also occurs in kidney allografts in transplanted patients, resulting in progressive kidney allograft dysfunction and, finally allograft loss with significant implications for patients' care and also financial implications for the healthcare system. However, early, noninvasive markers of IFTA or ongoing hypoxia in the kidney grafts are lacking. This is particularly problematic, since diagnosis of IFTA is often made late in the course of disease, and once IFTA develops, it is generally considered irreversible. There is thus an unmet clinical need to identify early markers of IFTA that could guide the use of novel anti-fibrotic therapies.
In patients with clinically decreasing allograft function or protienuria, indication (or for cause) biopsies are the gold standard test used to identify the cause for the functional decrease. However, biopsies carry significant procedural risk (e.g. bleeding and death) and suffer from a sampling bias - not all areas of the kidneys are accessible for biopsy and there is currently no way to target the fibrotic / hypoxic areas. Urine protein measurements are obviously also not suitable to resolve this clinical dilemma. There would thus be great clinical interest in developing non-invasive tools that could provide more information compared to traditional tests for monitoring renal hypoxia and injury through imaging and urinary biomarkers.
Our aims would be to image patients with different states of allograft function impairment and ideally find an imaging-based way to monitor those patients after transplantation. This way, an early detection of evolving interstitial fibrosis/tubular atrophy (IFTA) might be possible in a non-invasive way.The goal of this trial is to validate FAZA-PET/MR as a biomarker of hypoxia by correlating its uptake in patients with kidney allograft fibrosis with mass spectrometry based quantitative assays for monitoring of fibrotic markers in the urine of those same patients.
There would thus be great clinical interest in developing non-invasive tools that could provide more information compared to traditional tests for monitoring renal hypoxia and injury through imaging and urinary biomarkers. Whereas currently only allograft biopsy can be performed to detect (rather late stage) interstitial fibrosis/ tubular atrophy.
The study subjects' clinical management will not be changed based on the PET-MR scan within the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- FAZA PET/MRI Scan
| Arm | Type | Receives |
|---|---|---|
| FAZA PET/MRI scan | Other | Diagnostic Test: FAZA PET/MRI scanFAZA PET/MRI scan before the standard of care biopsy for case group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Evidence of impaired kidney graft function based on elevated serum creatinine from baseline and/ or evidence of significant proteinuria and/or donor specific antibodies
- A negative urine or serum pregnancy test within the three week interval immediately prior to imaging, in women of child-bearing age
- Ability to provide written informed consent to participate in the study (for both patients groups - with and without impaired kidney graft function)
- Two study groups:
Key exclusion criteria (4 listed)
- Contraindication for MR as per current institutional guidelines
- Inability to lie supine for at least 30 minutes
- Any patient who is pregnant or breastfeeding
- Any patient unable or unwilling 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 |
|---|---|---|
| FAZA PET/MRI scanFAZA PET/MRI scan before the standard of care biopsy for case group | Diagnostic test | FAZA PET/MRI scan |
Primary outcome
To image patients with different states of allograft function impairment and ideally find an imaging-based way to monitor those patients after transplantation
Time frame: Before the planned routine biopsy procedure for case patients
The FAZA uptake during the PET/MRI scan
To image patients with different states of allograft function impairment and ideally find an imaging-based way to monitor those patients after transplantation
Time frame: Through study completion once patient with stable graft function and minimal or no fibrosis on time zero biopsy and age matched graft age is identified. Up to 60 months
The FAZA uptake during the PET/MRI scan
2 secondary outcomes
Performing urine assays whereby AngII activity proteins in urine to predict the survival/viability outcome of the kidney allograft
Time frame: Before the planned routine biopsy procedure for case patients
Performing urine assays whereby AngII activity proteins in urine to predict the survival/viability outcome of the kidney allograft
Time frame: Through study completion once patient with stable graft function and minimal or no fibrosis on time zero biopsy and age matched graft age is identified. Up to 60 months
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 10 Apr 2024.
Related trials for Kidney Graft Fibrosis
RecruitingObservational study
Proteogenomic Monitoring and Assessment of Kidney Transplant Recipients
Acute Rejection (AR) of Transplanted Kidney, Chronic Allograft Nephropathy (CAN)
Enrolling by invitationPhase 2
Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation
Interstitial Fibrosis, Kidney Transplant; Complications
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.
Patrick Veit-Haibach, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAZA PET/MRI scan in people with Kidney Graft Fibrosis, run by University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 4 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 10 Apr 2024. 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 Canada. 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?
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?
To image patients with different states of allograft function impairment and ideally find an imaging-based way to monitor those patients after transplantation (time frame: Before the planned routine biopsy procedure for case patients). 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 10 Apr 2024.