Chronic Kidney Diseases
Conditions
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.
Interventions
DIAGNOSTIC_TESTMultiparametric 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
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
University of Nottingham
Queen Elizabeth University Hospital Glasgow
Royal Infirmary of Edinburgh
University of Edinburgh
Newcastle University
Newcastle-upon-Tyne Hospitals NHS Trust
University of Leeds
The Leeds Teaching Hospitals NHS Trust
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
Northern Care Alliance NHS Foundation Trust
University College, London
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CKD progression | 10 years | kidney failure (doubling of serum creatinine, eGFR\<15ml/min or RRT) OR a 40% decline in eGFR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kidney failure events | 10 years | Doubling of serum creatinine, eGFR\<15ml/min or RRT |
| 40% decline in eGFR from baseline | 10 years | — |
| eGFR trajectory | 2 years | (ml/min/yr) |
| AKI events | 4 years | AKI as per KDIGO serum creatinine criteria |
| Cardiovascular events | 4 years | — |
| All cause mortality | 10 years | — |
Countries
United Kingdom
Outcome results
None listed