Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000855729p
Ethics application status
Submitted, not yet approved
Date submitted
22/05/2022
Date registered
17/06/2022
Date last updated
22/05/2023
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Non-Invasive Magnetic Resonance Imaging Biomarkers to Evaluate Histology Proven Kidney Fibrosis in Chronic Kidney Disease
Scientific title
Non-Invasive Magnetic Resonance Imaging Biomarkers to Evaluate Histology Proven Kidney Fibrosis in Chronic Kidney Disease: A Pilot Study
Secondary ID [1] 307154 0
None
Universal Trial Number (UTN)
Trial acronym
NIMBLE-CKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 326356 0
Condition category
Condition code
Renal and Urogenital 323658 323658 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with chronic kidney disease (CKD) who require a kidney biopsy (native and transplant) will undergo contrast-enhanced kidney magnetic resonance imaging (MRI). The maximum anticipated time of scanning will be 1 hour, and participants will undergo a single scan within 7 days prior to their kidney biopsy. A single intravenous injection of a gadolinium-based contrast agent (Dotarem) will be administered at 0.05mmol/kg via a peripheral intravenous cannula. The scan will be conducted by a MRI radiographer, and an MRI safety checklist will be conducted for each participant prior to scanning.
Intervention code [1] 323609 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will include healthy volunteers without CKD who will undergo the same contrast-enhanced magnetic resonance imaging as the CKD cohort, however will not undergo kidney biopsy.
Control group
Active

Outcomes
Primary outcome [1] 331405 0
Percentage of kidney fibrosis quantified by histology in individuals with CKD
Timepoint [1] 331405 0
Kidney biopsy to be performed within 7 days of MRI
Secondary outcome [1] 409734 0
eGFR (ml/min/1.73m2) levels in individuals with chronic kidney disease calculated by serum (blood) creatinine.
Timepoint [1] 409734 0
Blood test to be performed within 2 weeks of MRI
Secondary outcome [2] 409735 0
Albuminuria (mg/mmol) levels in individuals with chronic kidney disease assessed by urinalysis.
Timepoint [2] 409735 0
Urinalysis to be performed within 4 weeks of MRI

Eligibility
Key inclusion criteria
All participants (CKD and healthy volunteers)
-Willing and able to provide informed consent

Healthy volunteers:
- No known medical conditions

CKD participants:
- Baseline eGFR > 15ml/min/1.73m2
- Clinical indication to undergo kidney biopsy (including native and transplanted kidney)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Contraindication to MRI
Contraindication to Gadolinium-based contrast agents
Dialysis dependent CKD
Pregnant or breastfeeding females

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A healthy control group (n=5) will determine a normal MRI reference range for baseline comparison. The disease control group will include those with minimal change disease on kidney biopsy as there will be no evidence of tubulointerstitial fibrosis. A derivation cohort (n=23) will be recruited to develop the model and a validation cohort (n=23) will be recruited to test the accuracy and sensitivity of the model. A multivariable linear regression model will be tested to determine the correlation between the MRI techniques outlined above and severity of kidney fibrosis on biopsy, level of eGFR and degree of albuminuria. All statistical tests will be performed at a 0.05 level of significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
1/04/2024
Actual
Date of last data collection
Anticipated
29/04/2024
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311404 0
Self funded/Unfunded
Name [1] 311404 0
Country [1] 311404 0
Primary sponsor type
Individual
Name
Professor Martin Ugander
Address
Kolling Institute
10 Westbourne St
St Leonards
NSW 2064
Country
Australia
Secondary sponsor category [1] 312793 0
Individual
Name [1] 312793 0
Muh Geot Wong
Address [1] 312793 0
Department of Renal Medicine
Concord Repatriation General Hospital
Hospital Rd
Concord
NSW 2139
Country [1] 312793 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310885 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 310885 0
Level 13, Kolling Building
Royal North Shore Hospital
Reserve Road
St Leonards
NSW 2065
Ethics committee country [1] 310885 0
Australia
Date submitted for ethics approval [1] 310885 0
29/05/2022
Approval date [1] 310885 0
Ethics approval number [1] 310885 0

Summary
Brief summary
Chronic kidney disease (CKD) is increasingly becoming more common, and is associated with increased disability and death rates. The best predictor for progression to kidney failure is the amount of kidney scarring detected on a biopsy. Biopsies are useful however are limited by their invasive nature and inability to collect large or multiple samples. MRI is used in other organs like the heart and the liver to check for scarring, but is not yet available for the kidney. The NIMBLE-CKD project aims to develop an MRI marker to estimate the amount of kidney scarring by comparing images with biopsy samples. Ultimately this will provide a less intrusive and safer way to detect and monitor CKD, with a hope to guide early treatment and prevent kidney failure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119226 0
Prof Martin Ugander
Address 119226 0
Kolling Institute
10 Westbourne St
St Leonards
NSW, 2064
Country 119226 0
Australia
Phone 119226 0
+61 481134220
Fax 119226 0
Email 119226 0
martin.ugander@sydney.edu.au
Contact person for public queries
Name 119227 0
Dr Dana Kim
Address 119227 0
Kolling Institute
10 Westbourne St
St Leonards
NSW, 2064
Country 119227 0
Australia
Phone 119227 0
+61 431710324
Fax 119227 0
Email 119227 0
dana.kim@sydney.edu.au
Contact person for scientific queries
Name 119228 0
Dr Dana Kim
Address 119228 0
Kolling Institute
10 Westbourne St
St Leonards
NSW, 2064
Country 119228 0
Australia
Phone 119228 0
+61 431710324
Fax 119228 0
Email 119228 0
dana.kim@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will be protected and kept confidential therefore will not be made available publically.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.