Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease (AFiRM)

University Hospitals of Derby and Burton NHS Foundation Trust

Status: Enrolling

Conditions: Chronic Kidney Diseases

Treatments: Diagnostic Test: Multiparametric renal MRI

Study type: Observational

Funder types: Other

Identifiers

NCT04238299

DHRD/2018/100

271043 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.)

Trial design

450 participants in 1 patient group

Main study cohort

Description:

Patients with CKD recruited from specialist nephrology clinics

Treatment:

Diagnostic Test: Multiparametric renal MRI