Clinical trial NCT04238299: Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease
Official title: Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Lead sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Queen Elizabeth University Hospital Glasgow
name: Royal Infirmary of Edinburgh
name: University of Edinburgh
name: Newcastle University
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: University of Leeds
name: The Leeds Teaching Hospitals NHS Trust
name: Sheffield Teaching Hospitals NHS Foundation Trust
name: University of Sheffield
name: Northern Care Alliance NHS Foundation Trust
name: University College, London
name: University of Cambridge
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2020-01-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic kidney disease

Brief 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: CKD progression
timeFrame: 10 years
Secondary outcomes:
measure: Kidney failure events
timeFrame: 10 years
measure: 40% decline in eGFR from baseline
timeFrame: 10 years
measure: eGFR trajectory
timeFrame: 2 years
measure: AKI events
timeFrame: 4 years
measure: Cardiovascular events
timeFrame: 4 years
measure: All cause mortality
timeFrame: 10 years
Other outcomes:
measure: Renal MRI measures
timeFrame: 2 years
measure: Renal histology measures
timeFrame: Baseline
Locations:
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
state: Derbyshire
Study officials:
References: