Renal Transplant RejectionPIKANCT03780101
Pathology and Imaging in Kidney Allografts
An observational study of Renal Transplant Rejection and Chronic Kidney Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
This study will perform multi-parametric renal MRI in 70 patients with a renal transplant who are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to compare findings on renal MRI with those seen on histology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Rejection, Chronic Kidney Diseases, Fibrosis
- What is being tested?
- Multi-parametric renal MRI
- How many people
- 29 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Feb 2019to 24 May 2022
- Phase
- Observational
- 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
Study population: Renal transplant recipients referred for a clinically-indicated biopsy of their transplant kidney
Who may be able to join
- Age > 18 years
- Recipient of a kidney transplant
- Referred for clinically indicated biopsy of transplant kidney
- Ability to comply with study procedures.
- Ability to give informed consent.
Who cannot join
- Any contraindication to MRI
- Known pregnancy or intent to conceive during the study period
- Clinical suspicion of delayed graft function as the cause of transplant dysfunction
- Any other reason considered by a study physician to make the subject inappropriate for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
This study will perform multi-parametric renal MRI in 70 patients with a renal transplant who are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to compare findings on renal MRI with those seen on histology.
Read the detailed description
Background: Renal transplantation is the optimal treatment for patients with renal failure. However, transplant life-span is finite and commonly limited due to the development of chronic rejection and other causes of irreversible fibrosis. At present, renal transplant biopsy is required to diagnose the cause of transplant dysfunction. Renal biopsies are invasive procedures that carry risks of bleeding, damage to the transplant and discomfort to patients. Functional magnetic resonance imaging (MRI) of the kidneys is an emerging field of research that has potential to non-invasively define and quantify parenchymal renal disease including fibrosis and inflammation. There is a paucity of data correlating multi-parametric renal MRI sequences with histological findings on biopsy, especially in patients with renal transplants.
Study participants: 70 adult renal transplant recipients who have been referred for a clinically indicated biopsy of their transplant kidney.
Study design: Participants will undergo multi-parametric renal MRI at time of biopsy. In patients who receive treatment for acute rejection, a second renal MRI will be undertaken at completion of treatment. Blood tests for fibrosis biomarkers and routine clinical measures of transplant function will be obtained at time of MRI scanning.
Objectives:
- Assess the correlation between functional renal MRI sequences and histological markers of fibrosis and inflammation.
- Assess the change in functional MRI sequences in response to treatment for acute rejection in renal transplant recipients.
- Being tested
- Multi-parametric renal MRI
- Medical subject headings
- Renal Insufficiency, Chronic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-parametric renal MRIDiagnostic test
Multi-parametric functional magnetic resonance imaging of a transplant kidney including sequences for T1, T2, diffusion-weighted imaging, diffusion tensor imaging and arterial spin labelling.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of MRI biomarkers for fibrosis with histology
Correlation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis.
Measured: Baseline
Secondary outcomes (1)
Renal MRI following treatment for acute rejection
Correlation between change in native T1 and serum creatinine following treatment for acute rejection.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start15 Feb 2019
- Primary completion24 May 2022
- Study completion24 May 2022
Why it stopped: recruitment difficulties due to impact of COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alastair J Rankin, MBChB, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780101
- Sponsor's protocol ID
- GN18RE474
- Other IDs
- 248675
- Acronym
- PIKA
- Status last verified
- May 2022
- First submitted
- 17 Dec 2018
- Last updated
- 3 Jun 2022
- 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 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathology and Imaging in Kidney Allografts
- ClinicalTrials.gov ID
- NCT03780101
- Acronym / sponsor ID
- PIKA / GN18RE474
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties due to impact of COVID-19 pandemic
- Enrolment
- 29 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 19 Dec 2018 (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 study will perform multi-parametric renal MRI in 70 patients with a renal transplant who are undergoing a clinically indicated biopsy of their transplant. The aim of this study is to compare findings on renal MRI with those seen on histology.
Detailed description
Background: Renal transplantation is the optimal treatment for patients with renal failure. However, transplant life-span is finite and commonly limited due to the development of chronic rejection and other causes of irreversible fibrosis. At present, renal transplant biopsy is required to diagnose the cause of transplant dysfunction. Renal biopsies are invasive procedures that carry risks of bleeding, damage to the transplant and discomfort to patients. Functional magnetic resonance imaging (MRI) of the kidneys is an emerging field of research that has potential to non-invasively define and quantify parenchymal renal disease including fibrosis and inflammation. There is a paucity of data correlating multi-parametric renal MRI sequences with histological findings on biopsy, especially in patients with renal transplants.
Study participants: 70 adult renal transplant recipients who have been referred for a clinically indicated biopsy of their transplant kidney.
Study design: Participants will undergo multi-parametric renal MRI at time of biopsy. In patients who receive treatment for acute rejection, a second renal MRI will be undertaken at completion of treatment. Blood tests for fibrosis biomarkers and routine clinical measures of transplant function will be obtained at time of MRI scanning.
Objectives:
- Assess the correlation between functional renal MRI sequences and histological markers of fibrosis and inflammation.
- Assess the change in functional MRI sequences in response to treatment for acute rejection in renal transplant recipients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Renal transplant recipients referred for a clinically-indicated biopsy of their transplant kidney
Key inclusion criteria (5 listed)
- Age > 18 years
- Recipient of a kidney transplant
- Referred for clinically indicated biopsy of transplant kidney
- Ability to comply with study procedures.
- Ability to give informed consent.
Key exclusion criteria (4 listed)
- Any contraindication to MRI
- Known pregnancy or intent to conceive during the study period
- Clinical suspicion of delayed graft function as the cause of transplant dysfunction
- Any other reason considered by a study physician to make the subject inappropriate for inclusion.
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 |
|---|---|---|
| Multi-parametric renal MRIMulti-parametric functional magnetic resonance imaging of a transplant kidney including sequences for T1, T2, diffusion-weighted imaging, diffusion tensor imaging and arterial spin labelling. | Diagnostic test | – |
Primary outcome
Comparison of MRI biomarkers for fibrosis with histology
Time frame: Baseline
Correlation between diffusion weighted imaging on renal MRI and reported percentage of cortical area on biopsy showing interstitial fibrosis.
1 secondary outcome
Renal MRI following treatment for acute rejection
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: recruitment difficulties due to impact of COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- 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.
Alastair J Rankin, MBChB principal investigator
University of Glasgow
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 Renal Transplant Rejection and Chronic Kidney Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 5 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: stopped early, as of the sponsor's last update on 3 Jun 2022. 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 Kingdom. 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 was stopped early (reason given: recruitment difficulties due to impact of COVID-19 pandemic). 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?
Comparison of MRI biomarkers for fibrosis with histology (time frame: Baseline). 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 3 Jun 2022.