Renal MR Feasibility in Renal Disease

NCT03578523 | Unknown

• 1 other identifier: 15040
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To use Non-invasive MR Imaging of Renal Physiology and structure to assess patients with Acute Kidney Injury (AKI) and Chronic Kidney Disease (CKD).

Conditions

Renal Disease

Outcome Measures

Primary Outcomes (3)

• The difference between volume (mls) MR parameter between healthy volunteers and patients with CKD and AKI

  Examining the difference in volume (mls) T1 (ms) between the 3 groups using PRISM, SPSS, Stata and Matlab

  3 years

• The difference between T1 (ms) MR parameter between healthy volunteers and patients with CKD and AKI

  Examining the difference in T1 (ms) between the 3 groups using PRISM, SPSS, Stata and Matlab

  3 years

• The difference between Diffusion weighted imaging MR parameter between healthy volunteers and patients with CKD and AKI

  Examining the difference in ADC and D(ms) between the 3 groups using PRISM, SPSS, Stata and Matlab

  3 years

Secondary Outcomes (4)

• Correlations between structural T1 (ms) and blinded renal biopsy measurements

  3 years

• Correlations between structural MR measurement: T1(ms) and creatinine(µmols),

  3 years

• Correlations between structural diffusion weighted imaging and blinded renal biopsy measurements

  3 years

• Correlations between structural MR measurement: diffusion weighted imaging and eGFR mls/min.1.73m

  3 years

Study Arms (2)

Chronic Kidney Disease

CKD stage 3-4 eGFR 59-20mls/min/1.73 '3 Tesla multiparametric MR: Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion). Each patient will have 3 renal MRI scans. renal histopathology scoring: Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication) Iohexol clearance test: Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel. urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis. Iohexol clearance to measure GFR within 1 week of the scan session

Other: 3 Tesla multiparametric MR; Other: renal histopathology scoring; Biological: Blood and urine sampling; Biological: Iohexol clearance test

Acute Kidney Injury

AKI stage 2-3 '3 Tesla multiparametric MR: Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion). Each patient will have 3 renal MRI scans. Iohexol clearance test: Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel. renal histopathology scoring: Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication) urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis. Iohexol clearance to measure GFR within 1 week of the scan session

Other: 3 Tesla multiparametric MR; Other: renal histopathology scoring; Biological: Blood and urine sampling; Biological: Iohexol clearance test

Interventions

3 Tesla multiparametric MR OTHER

Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion). Each patient will have 3 renal MRI scans.

Also known as: Renal MRI Scan

Acute Kidney Injury; Chronic Kidney Disease

renal histopathology scoring OTHER

Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication)

Acute Kidney Injury; Chronic Kidney Disease

Blood and urine sampling BIOLOGICAL

Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel, urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis

Acute Kidney Injury; Chronic Kidney Disease

Iohexol clearance test BIOLOGICAL

Iohexol clearance to measure GFR within 1 week of the scan session

Acute Kidney Injury; Chronic Kidney Disease

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

secondary care patients 1. chronic kidney disease stage 3-4 post renal biopsy 2. Acute kidney injury stage 2-3 during hospital admission

You may qualify if:

• AKI Patients:
• Acute Kidney Injury stage 2/3 (duration \>24 hours) including patients requiring renal replacement therapy
• \>18 years \& \< 95 years
• Able to give informed consent
• CKD Patients:
• Patients with CKD Stage 3 - 4 (e GFR\> 20 and \<60 ml/min)
• \>18 years \& \< 95 years
• Able to give informed consent

You may not qualify if:

• AKI Patients:
• Renal transplant
• Contraindications to MRI e.g. claustrophobia, cardiac pacemaker, metallic fragments or implants
• Pregnancy or breast feeding or intending pregnancy
• Unable to give consent or understand written information
• Pre-existing CKD of any stage as per eGFR
• Obstructive uropathy
• AKI duration \<24hrs, in the opinion of the investigator
• Not medically fit for transfer to MRI scan, in the opinion of the clinical team or the investigator
• Iodine allergy
• Patients unable to comply with basic verbal English commands whilst in scanner due to special communication needs
• CKD Patients:
• Renal transplant
• Contraindications to MRI e.g. claustrophobia, cardiac pacemaker, metallic fragments or implants
• Pregnancy or breast feeding or intending pregnancy

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital

Derby, East Midlands, de223ne, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine samples will be collected

MeSH Terms

Conditions

Kidney Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Maarten Taal

  univeristy of nottingham

  PRINCIPAL INVESTIGATOR

• nick selby

  University of Nottingham

  STUDY CHAIR

Central Study Contacts

Huda Mahmoud, MBChB

CONTACT

01332724365; huda.mahmoud@nottingham.ac.uk

Study Design

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

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 6, 2018
• Study Start: October 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)