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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Diagnostic test: Multiparametric renal 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.

• Study Type: Observational
• Enrollment (Actual): 486

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3NE
      • Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chronic kidney disease

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main study cohort; Patients with CKD recruited from specialist nephrology clinics	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CKD progression	kidney failure (doubling of serum creatinine, eGFR<15ml/min or RRT) OR a 40% decline in eGFR	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney failure events	Doubling of serum creatinine, eGFR<15ml/min or RRT	10 years
40% decline in eGFR from baseline		10 years
eGFR trajectory	(ml/min/yr)	2 years
AKI events	AKI as per KDIGO serum creatinine criteria	4 years
Cardiovascular events		4 years
All cause mortality		10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal MRI measures	As detailed in interventions section	2 years
Renal histology measures	Glomerulosclerosis score, extent of interstitial fibrosis, inflammation, peritubular capillary density, collagen accumulation, inflammatory cell subtypes	Baseline

Collaborators and Investigators

• Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust
• Collaborators: University of Nottingham; Northern Care Alliance NHS Foundation Trust; University College, London; The Leeds Teaching Hospitals NHS Trust; University of Leeds; Cambridge University Hospitals NHS Foundation Trust; University of Sheffield; Sheffield Teaching Hospitals NHS Foundation Trust; University of Edinburgh; Newcastle University; University of Cambridge; Newcastle-upon-Tyne Hospitals NHS Trust; Royal Infirmary of Edinburgh; Queen Elizabeth University Hospital Glasgow

Publications and helpful links

Helpful Links

• Derby Clinical Trials Support Unit

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2033

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: DHRD/2018/100; 271043 (Other Identifier: IRAS)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No