Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease

NCT ID: NCT04238299

Last Updated: 2023-03-31

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2033-02-28

Brief Summary

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Research question: Can multiparametric renal Magnetic Resonance Imaging (MRI) provide structural and functional assessment of the kidneys to deliver prognostic information and guide treatment options in chronic kidney disease (CKD)?

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.

Detailed Description

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The study will have three stages.

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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Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Main study cohort

Patients with CKD recruited from specialist nephrology clinics

Multiparametric renal MRI

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age 18-75 years
* CKD category G3-4 or CKD category G1-2 with overt albuminuria (urine ACR\>30mg/mmol)
* Capable of giving informed consent

Exclusion Criteria

* Autosomal dominant polycystic kidney disease (ADPKD)
* 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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nottingham

OTHER

Sponsor Role collaborator

Queen Elizabeth University Hospital Glasgow

UNKNOWN

Sponsor Role collaborator

Royal Infirmary of Edinburgh

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role collaborator

Newcastle University

OTHER

Sponsor Role collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Sheffield

OTHER

Sponsor Role collaborator

Northern Care Alliance NHS Foundation Trust

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

University of Cambridge

OTHER

Sponsor Role collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Derby Hospital

Derby, Derbyshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Nicholas Selby

Role: CONTACT

01332 724665

Rachelle Sherman

Role: CONTACT

01332724736

Facility Contacts

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Nicholas Selby

Role: primary

01332 724665

Maarten Taal

Role: backup

01332 724918

Related Links

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https://www.uhdb.nhs.uk/derby-ctu

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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