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NCT Number: NCT04238299

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

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Multiparametric renal MRI

Diagnostic Test

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

Primary outcomes

  1. CKD progression

    Time frame: 10 years

    kidney failure (doubling of serum creatinine, eGFR<15ml/min or RRT) OR a 40% decline in eGFR

Secondary outcomes

  1. Kidney failure events

    Time frame: 10 years

    Doubling of serum creatinine, eGFR<15ml/min or RRT

  2. 40% decline in eGFR from baseline

    Time frame: 10 years

  3. eGFR trajectory

    Time frame: 2 years

    (ml/min/yr)

  4. AKI events

    Time frame: 4 years

    AKI as per KDIGO serum creatinine criteria

  5. Cardiovascular events

    Time frame: 4 years

  6. All cause mortality

    Time frame: 10 years

Other outcomes

  1. Renal MRI measures

    Time frame: 2 years

    As detailed in interventions section

  2. Renal histology measures

    Time frame: Baseline

    Glomerulosclerosis score, extent of interstitial fibrosis, inflammation, peritubular capillary density, collagen accumulation, inflammatory cell subtypes

Sponsors and collaborators

Lead sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Other

Collaborators

  • 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

Registry information

Acronym: AFiRM

Important dates

Study start
2021
Primary completion
2027
Study completion
2033
First posted
Jan 23, 2020
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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