Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease
NCT ID: NCT04238299
Last Updated: 2023-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2021-06-01
2033-02-28
Brief Summary
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Aims and objectives:
1. To establish a multiparametric renal MRI protocol in CKD cohorts.
2. To use multiparametric MRI to characterise people with and without CKD progression.
3. To compare multiparametric renal MRI with 'gold-standard' renal biopsy to determine pathological processes of CKD progression that are detectable by MRI.
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Detailed Description
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Stage 1: 45 people with CKD from nine UKRIN centres will undergo multiparametric MRI to test patient tolerance, data completeness and central data collection processes.
Stage 2: A multicentre, prospective cohort study of 450 people with CKD, collecting multiparametric renal MRI at baseline and 2 years. Long-term outcomes will be determined with efficient tracking of kidney failure events via the UK Renal Registry at 5 and 10 years.
Stage 3: A mechanistic sub-study of 45 patients (from Stage 2) who have had a routine renal biopsy. Detailed comparisons will be made between multiparametric MRI and histopathological changes. Tissue blocks will undergo quantitative analysis of fibrosis, capillary density and inflammation using immunohistochemistry techniques.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Main study cohort
Patients with CKD recruited from specialist nephrology clinics
Multiparametric renal MRI
Localiser scans; Kidney volume; Longitudinal (T1) relaxation time mapping; Diffusion weighted imaging (DWI); Phase Contrast MRI; Arterial spin labelling (ASL); Blood Oxygen Level Dependent (BOLD) mapping
Interventions
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Multiparametric renal MRI
Localiser scans; Kidney volume; Longitudinal (T1) relaxation time mapping; Diffusion weighted imaging (DWI); Phase Contrast MRI; Arterial spin labelling (ASL); Blood Oxygen Level Dependent (BOLD) mapping
Eligibility Criteria
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Inclusion Criteria
* CKD category G3-4 or CKD category G1-2 with overt albuminuria (urine ACR\>30mg/mmol)
* Capable of giving informed consent
Exclusion Criteria
* Glomerulonephritis (GN) actively receiving immunosuppression, or within the preceding 90 days.
* Multiple myeloma (MM)
* Acute Kidney Injury (AKI) within the preceding 90 days
* Solid organ transplant
* Known single kidney
* Contraindications to MRI (e.g. permanent pacemaker, metallic foreign bodies, claustrophobia etc.)
18 Years
75 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Queen Elizabeth University Hospital Glasgow
UNKNOWN
Royal Infirmary of Edinburgh
OTHER
University of Edinburgh
OTHER
Newcastle University
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
University of Leeds
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
University of Sheffield
OTHER
Northern Care Alliance NHS Foundation Trust
OTHER
University College, London
OTHER
University of Cambridge
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
University Hospitals of Derby and Burton NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Royal Derby Hospital
Derby, Derbyshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Derby Clinical Trials Support Unit
Other Identifiers
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271043
Identifier Type: OTHER
Identifier Source: secondary_id
DHRD/2018/100
Identifier Type: -
Identifier Source: org_study_id
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