Renal DiseaseREMINDNCT03578523
Renal MR Feasibility in Renal Disease
An observational study of Renal Disease, run by University of Nottingham at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Renal Disease
- What is being tested?
- 3 Tesla multiparametric MR, renal histopathology scoring and Blood and urine sampling
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Derby Hospital
Derby, East Midlands, de223ne
About this study
Official title: Using MRI ASL Techniques for Quantitative Measurement of Renal Haemodynamics and Structural Parameters in Acute Kidney Injury and Chronic Kidney Disease.
To use Non-invasive MR Imaging of Renal Physiology and structure to assess patients with Acute Kidney Injury (AKI) and Chronic Kidney Disease (CKD).
Read the 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
- Being tested
- 3 Tesla multiparametric MR, renal histopathology scoring, Blood and urine sampling, Iohexol clearance test
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 Tesla multiparametric MROther
Also called Renal MRI Scan
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 scoringOther
Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication)
Blood and urine samplingBiological
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 testBiological
Iohexol clearance to measure GFR within 1 week of the scan session
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: 3 Tesla multiparametric MR; Other: renal histopathology scoring; Biological: Blood and urine sampling; Biological: Iohexol clearance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 years
Secondary outcomes (4)
Correlations between structural T1 (ms) and blinded renal biopsy measurements
Sirius red fibrosis scoring (%) Vs T1(ms)
Measured: 3 years
Correlations between structural MR measurement: T1(ms) and creatinine(µmols),
T1 (ms) vs creatinine (µmols)
Measured: 3 years
Correlations between structural diffusion weighted imaging and blinded renal biopsy measurements
Sirius red fibrosis scoring (%) Vs ADC and D (ms)
Measured: 3 years
Correlations between structural MR measurement: diffusion weighted imaging and eGFR mls/min.1.73m
ADC and D (ms) vs eGFR mls/min.1.73m
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study startOct 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maarten Taal, Principal investigator, univeristy of nottinghamnick selby, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578523
- Sponsor's protocol ID
- 15040
- Acronym
- REMIND
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2016
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using MRI ASL Techniques for Quantitative Measurement of Renal Haemodynamics and Structural Parameters in Acute Kidney Injury and Chronic Kidney Disease.
- ClinicalTrials.gov ID
- NCT03578523
- Acronym / sponsor ID
- REMIND / 15040
- Conditions
- Renal Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Kidney Disease | – | Other: 3 Tesla multiparametric MR, Other: renal histopathology scoring, Biological: Blood and urine sampling, Biological: Iohexol clearance testCKD 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 |
| Acute Kidney Injury | – | Other: 3 Tesla multiparametric MR, Other: renal histopathology scoring, Biological: Blood and urine sampling, Biological: Iohexol clearance testAKI 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 |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- Acute Kidney Injury stage 2/3 (duration >24 hours) including patients requiring renal replacement therapy
- >18 years \& < 95 years
- Able to give informed consent
- Patients with CKD Stage 3 - 4 (e GFR> 20 and <60 ml/min)
- >18 years \& < 95 years
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 Tesla multiparametric MRAlso: Renal MRI ScanRenal 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 | Acute Kidney Injury, Chronic Kidney Disease |
| renal histopathology scoringBlinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication) | Other | Acute Kidney Injury, Chronic Kidney Disease |
| Blood and urine samplingBlood 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 | Acute Kidney Injury, Chronic Kidney Disease |
| Iohexol clearance testIohexol clearance to measure GFR within 1 week of the scan session | Biological | Acute Kidney Injury, Chronic Kidney Disease |
Primary outcome
The difference between volume (mls) MR parameter between healthy volunteers and patients with CKD and AKI
Time frame: 3 years
Examining the difference in volume (mls) T1 (ms) between the 3 groups using PRISM, SPSS, Stata and Matlab
The difference between T1 (ms) MR parameter between healthy volunteers and patients with CKD and AKI
Time frame: 3 years
Examining the difference in T1 (ms) between the 3 groups using PRISM, SPSS, Stata and Matlab
The difference between Diffusion weighted imaging MR parameter between healthy volunteers and patients with CKD and AKI
Time frame: 3 years
Examining the difference in ADC and D(ms) between the 3 groups using PRISM, SPSS, Stata and Matlab
4 secondary outcomes
Correlations between structural T1 (ms) and blinded renal biopsy measurements
Time frame: 3 years
Correlations between structural MR measurement: T1(ms) and creatinine(µmols),
Time frame: 3 years
Correlations between structural diffusion weighted imaging and blinded renal biopsy measurements
Time frame: 3 years
Correlations between structural MR measurement: diffusion weighted imaging and eGFR mls/min.1.73m
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maarten Taal principal investigator
univeristy of nottingham
nick selby study chair
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Disease, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huda Mahmoud, MBChB (01332724365, huda.mahmoud@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between volume (mls) MR parameter between healthy volunteers and patients with CKD and AKI (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.