NCT04238299

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. 1.To establish a multiparametric renal MRI protocol in CKD cohorts.
  2. 2.To use multiparametric MRI to characterise people with and without CKD progression.
  3. 3.To compare multiparametric renal MRI with 'gold-standard' renal biopsy to determine pathological processes of CKD progression that are detectable by MRI.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
83mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jun 2021Feb 2033

First Submitted

Initial submission to the registry

January 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2033

Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

5.7 years

First QC Date

January 20, 2020

Last Update Submit

March 30, 2023

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • CKD progression

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

    10 years

Secondary Outcomes (6)

  • Kidney failure events

    10 years

  • 40% decline in eGFR from baseline

    10 years

  • eGFR trajectory

    2 years

  • AKI events

    4 years

  • Cardiovascular events

    4 years

  • +1 more secondary outcomes

Other Outcomes (2)

  • Renal MRI measures

    2 years

  • Renal histology measures

    Baseline

Study Arms (1)

Main study cohort

Patients with CKD recruited from specialist nephrology clinics

Diagnostic Test: Multiparametric renal MRI

Interventions

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

Main study cohort

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic kidney disease

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE22 3NE, United Kingdom

RECRUITING

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Nicholas Selby

CONTACT

01332 724665nicholas.selby@nottingham.ac.uk

Rachelle Sherman

CONTACT

01332724736uhdb.afirmstudy@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 23, 2020

Study Start

June 1, 2021

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2033

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations

GB(1)