Application of Functional Renal MRI to Improve Assessment... | NCT04238299

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

NCT04238299

Sponsor

University Hospitals of Derby and Burton NHS Foundation Trust

Status

Active, not recruiting

Last Update Posted

May 12, 2026Actual

Enrollment

486Actual

Phase

Not provided

Conditions

Chronic Kidney Diseases

Interventions

Multiparametric renal MRI

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
271043	Other Identifier	IRAS

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Feb 28, 2027Estimated

Completion Date

Feb 28, 2033Estimated

First Submitted Date

Jan 20, 2020

First Submission Date that Met QC Criteria

Jan 20, 2020

First Posted Date

Jan 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

University Hospitals of Derby and Burton NHS Foundation TrustOTHER

Collaborators

Name	Class
University of Nottingham	OTHER
Queen Elizabeth University Hospital Glasgow	UNKNOWN
Royal Infirmary of Edinburgh	OTHER
University of Edinburgh

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

486Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Main study cohort		Patients with CKD recruited from specialist nephrology clinics	Diagnostic Test: Multiparametric renal MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Kidney failure events	Doubling of serum creatinine, eGFR<15ml/min or RRT	10 years
40% decline in eGFR from baseline		10 years

Other Outcomes

Measure	Description	Time Frame
Renal MRI measures	As detailed in interventions section	2 years
Renal histology measures	Glomerulosclerosis score, extent of interstitial fibrosis, inflammation, peritubular capillary density, collagen accumulation, inflammatory cell subtypes

Eligibility Module

Eligibility Criteria

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Chronic kidney disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Derby Hospital		Derby	Derbyshire	DE22 3NE	United Kingdom

Label	URL
Derby Clinical Trials Support Unit	View source

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

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Browse Branches

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