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Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease (AFiRM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04238299
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : February 20, 2020
Sponsor:
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
Salford Royal NHS Foundation Trust
University College, London
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
University Hospitals of Derby and Burton NHS Foundation Trust

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.

Condition or disease Intervention/treatment
Chronic Kidney Diseases Diagnostic Test: Multiparametric renal 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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples With DNA
Stored samples: plasma, serum, urine and DNA at study entry Multiparametric renal MRI measures at study entry and after 2 years of follow up


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic kidney disease
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.)

Information from the National Library of Medicine

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


Contacts
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Contact: Nicholas Selby 01332 724665 nicholas.selby@nottingham.ac.uk
Contact: Rachelle Sherman 01332724736 uhdb.afirmstudy@nhs.net

Sponsors and Collaborators
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
Salford Royal NHS Foundation Trust
University College, London
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Additional Information:
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Responsible Party: University Hospitals of Derby and Burton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04238299    
Other Study ID Numbers: DHRD/2018/100
271043 ( Other Identifier: IRAS )
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency