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

Chronic Kidney Diseases Clinical Trial

— AFiRM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04238299
• Other study ID #: DHRD/2018/100
• Secondary ID: 271043
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: February 28, 2033

Study information

• Verified date: March 2023
• Source: University Hospitals of Derby and Burton NHS Foundation Trust
• Contact: Nicholas Selby
• Phone: 01332 724665
• Email: nicholas.selby[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: February 28, 2033
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby	Derbyshire

Sponsors (15)

Lead Sponsor

Collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

Cambridge University Hospitals NHS Foundation Trust, Newcastle University, Newcastle-upon-Tyne Hospitals NHS Trust, Northern Care Alliance NHS Foundation Trust, Queen Elizabeth University Hospital Glasgow, Royal Infirmary of Edinburgh, Sheffield Teaching Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, University College, London, University of Cambridge, University of Edinburgh, University of Leeds, University of Nottingham, University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Renal MRI measures	As detailed in interventions section	2 years
Other	Renal histology measures	Glomerulosclerosis score, extent of interstitial fibrosis, inflammation, peritubular capillary density, collagen accumulation, inflammatory cell subtypes	Baseline
Primary	CKD progression	kidney failure (doubling of serum creatinine, eGFR<15ml/min or RRT) OR a 40% decline in eGFR	10 years
Secondary	Kidney failure events	Doubling of serum creatinine, eGFR<15ml/min or RRT	10 years
Secondary	40% decline in eGFR from baseline		10 years
Secondary	eGFR trajectory	(ml/min/yr)	2 years
Secondary	AKI events	AKI as per KDIGO serum creatinine criteria	4 years
Secondary	Cardiovascular events		4 years
Secondary	All cause mortality		10 years

External Links

•   Derby Clinical Trials Support Unit