NCT04238299

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Chronic Kidney Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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

Timeline

• Start date: 2021-06-01
• Primary completion: 2027-02-28
• Completion: 2033-02-28
• First posted: 2020-01-23
• Last updated: 2023-03-31

Locations

1 site across 1 country: United Kingdom