NCT03578523

Renal MR Feasibility in Renal Disease

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Renal Disease

Interventions

Type	Name	Description
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.
OTHER	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
BIOLOGICAL	Iohexol clearance test	Iohexol clearance to measure GFR within 1 week of the scan session

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2018-07-06
• Last updated: 2018-07-06

Locations

1 site across 1 country: United Kingdom