Renal MR Feasibility in Renal Disease

Renal Disease Clinical Trial

— REMIND  

Official title:

Using MRI ASL Techniques for Quantitative Measurement of Renal Haemodynamics and Structural Parameters in Acute Kidney Injury and Chronic Kidney Disease.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03578523
• Other study ID #: 15040
• Status: Recruiting
• Start date: October 2015
• Est. completion date: December 2020

Study information

• Verified date: July 2018
• Source: University of Nottingham
• Contact: Huda Mahmoud, MBChB
• Phone: 01332724365
• Email: huda.mahmoud[@]nottingham.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Multi centre observational pilot study using novel, contrast free functional renal MRI scans.

A series of functional renal MRI scans will be performed (These scans do not constitute part patients routine clinical care). The results will initially be used to assess renal perfusion and fibrosis in patients with AKI and CKD. Subsequent analysis will be used to identify specific markers on the renal MRI scans that differentiate chronic kidney damage from acute injury to the kidney. Finally results will be used to stratify patients with AKI and CKD into low and high risk of subsequent deterioration in renal function.

AKI Cohort

25 patients with AKI stage 2/3 with or without renal replacement therapy (RRT) will undergo functional renal MRI imaging at day 0, day 90 and day 365.

First Study Scan (Day 0): A functional renal MRI scan will be performed during an admission to hospital with an episode of AKI 2/3. Vital signs and SOFA score will be recorded on the day of the scan.

Renal function assessment will occur± 2 days either side of the scan with an Iohexol clearance test.

Second Study Scan (Day 90): Repeat functional renal MRI imaging will be planned at 90 days (±14 days) after the 1st study scan day.

Renal function assessment will occur±7 days either side of the scan with an Iohexol clearance test.

Third Study Scan (Day 365): The final functional renal MRI imaging will take place 12 months (±30 days) after the 1st study scan day. Renal function assessment will occur±7 days either side of the scan with an Iohexol clearance test.

CKD Cohort:

25 patients with CKD stage 3-4 eGFR 20-59ml/min/1.73m2 will undergo functional renal MRI imaging at day 0, day 7 and day 365.

First Study Scan (Day 0): A functional renal MRI scan will be performed as an outpatient. Vital signs will be recorded on the day of the scan.

Renal function assessment will occur ±7 days either side of the scan with an Iohexol clearance test.

Second Study Scan (Day 7): A functional renal MRI scan will be performed as an outpatient. Vital signs will be recorded on the day of the scan.

Third Study Scan (Day 365): The second functional renal MRI imaging will take place 12 months (±30 days) after the 1st study scan day. Renal function assessment will occur±7 days either side of the scan with an Iohexol clearance test.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

• Unable to give consent or understand written information

• Unstable CKD; AKI Stage 1 or more or other unplanned hospital admission within the last 90 days

• Iodine allergy

• Patients unable to comply with basic verbal English commands whilst in scanner due to special communication needs

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Disease

Intervention

Other:
• 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)

Biological:
• Blood and urine sampling
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 test
Iohexol clearance to measure GFR within 1 week of the scan session

Locations

Country	Name	City	State
United Kingdom	Royal Derby Hospital	Derby	East Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Correlations between structural T1 (ms) and blinded renal biopsy measurements	Sirius red fibrosis scoring (%) Vs T1(ms)	3 years
Secondary	Correlations between structural MR measurement: T1(ms) and creatinine(µmols),	T1 (ms) vs creatinine (µmols)	3 years
Secondary	Correlations between structural diffusion weighted imaging and blinded renal biopsy measurements	Sirius red fibrosis scoring (%) Vs ADC and D (ms)	3 years
Secondary	Correlations between structural MR measurement: diffusion weighted imaging and eGFR mls/min.1.73m	ADC and D (ms) vs eGFR mls/min.1.73m	3 years