Chronic Kidney DiseasesAFiRMNCT04238299
Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease
An observational study of Chronic Kidney Diseases, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Multiparametric renal MRI
- How many people
- 486 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2021to 28 Feb 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic kidney disease
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Multiparametric renal MRI
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric renal MRIDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Main study cohort | Patients with CKD recruited from specialist nephrology clinics Receives: Diagnostic Test: Multiparametric renal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
CKD progression
kidney failure (doubling of serum creatinine, eGFR<15ml/min or RRT) OR a 40% decline in eGFR
Measured: 10 years
Secondary outcomes (6)
Kidney failure events
Doubling of serum creatinine, eGFR<15ml/min or RRT
Measured: 10 years
40% decline in eGFR from baseline
Measured: 10 years
eGFR trajectory
(ml/min/yr)
Measured: 2 years
AKI events
AKI as per KDIGO serum creatinine criteria
Measured: 4 years
Cardiovascular events
Measured: 4 years
All cause mortality
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Jun 2021
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238299
- Sponsor's protocol ID
- DHRD/2018/100
- Other IDs
- 271043
- Acronym
- AFiRM
- Status last verified
- May 2026
- First submitted
- 20 Jan 2020
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04238299
- Acronym / sponsor ID
- AFiRM / DHRD/2018/100
- Conditions
- Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 486 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- 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 start
- 1 Jun 2021 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2033 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study cohort | – | Diagnostic Test: Multiparametric renal MRIPatients with CKD recruited from specialist nephrology clinics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic kidney disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric renal MRILocaliser 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 | Diagnostic test | Main study cohort |
Primary outcome
CKD progression
Time frame: 10 years
kidney failure (doubling of serum creatinine, eGFR<15ml/min or RRT) OR a 40% decline in eGFR
6 secondary outcomes
Kidney failure events
Time frame: 10 years
40% decline in eGFR from baseline
Time frame: 10 years
eGFR trajectory
Time frame: 2 years
AKI events
Time frame: 4 years
Cardiovascular events
Time frame: 4 years
All cause mortality
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Derby Clinical Trials Support UnitLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CKD progression (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.