Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease (AFiRM)
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|ClinicalTrials.gov Identifier: NCT04238299|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : February 20, 2020
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:
- To establish a multiparametric renal MRI protocol in CKD cohorts.
- To use multiparametric MRI to characterise people with and without CKD progression.
- To compare multiparametric renal MRI with 'gold-standard' renal biopsy to determine pathological processes of CKD progression that are detectable by MRI.
|Condition or disease||Intervention/treatment|
|Chronic Kidney Diseases||Diagnostic Test: Multiparametric renal MRI|
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|
|Estimated Enrollment :||450 participants|
|Official Title:||Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease|
|Estimated Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||February 28, 2027|
|Estimated Study Completion Date :||February 28, 2033|
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
- CKD progression [ Time Frame: 10 years ]kidney failure (doubling of serum creatinine, eGFR<15ml/min or RRT) OR a 40% decline in eGFR
- Kidney failure events [ Time Frame: 10 years ]Doubling of serum creatinine, eGFR<15ml/min or RRT
- 40% decline in eGFR from baseline [ Time Frame: 10 years ]
- eGFR trajectory [ Time Frame: 2 years ](ml/min/yr)
- AKI events [ Time Frame: 4 years ]AKI as per KDIGO serum creatinine criteria
- Cardiovascular events [ Time Frame: 4 years ]
- All cause mortality [ Time Frame: 10 years ]
- Renal MRI measures [ Time Frame: 2 years ]As detailed in interventions section
- Renal histology measures [ Time Frame: Baseline ]Glomerulosclerosis score, extent of interstitial fibrosis, inflammation, peritubular capillary density, collagen accumulation, inflammatory cell subtypes
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238299
|Contact: Nicholas Selby||01332 firstname.lastname@example.org|
|Contact: Rachelle Shermanemail@example.com|