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

Recruiting

• Conditions: Chronic Kidney Diseases

• Registration Number: NCT04238299
• Lead Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-23
• Study Start: 2021-06-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-30
• Last Update Posted: 2023-03-31
• Primary Completion: 2027-02-28
• Study Completion: 2033-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Royal Derby Hospital; 🇬🇧 Derby, Derbyshire, United Kingdom