Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001030167
Ethics application status
Approved
Date submitted
20/06/2019
Date registered
18/07/2019
Date last updated
6/12/2021
Date data sharing statement initially provided
18/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Queensland Renal Biopsy Registry
Scientific title
Queensland Renal Biopsy Registry: a platform to improve patient care and validate new care strategies
Secondary ID [1] 298551 0
Nil known
Universal Trial Number (UTN)
U1111-1235-7561
Trial acronym
QRBR
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Renal Biopsy Registry 313372 0
Glomerulonephritis 313375 0
Acute Kidney Injury 313376 0
Renal transplant 313378 0
Chronic Kidney disease 313379 0
Condition category
Condition code
Renal and Urogenital 311814 311814 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational Study
Data of the patients who underwent Kidney biopsy are collected in this registry including demographics, investigations including kidney biopsy findings, treatment administered. Participants consent is waived for retrospective collection of data who underwent biopsy till 2018. New Participants ( 2019 onwards) who underwent kidney biopsy consent will be obtained to access the records . All the participants data will be collected - whenever there is occasion of service till they are followed up .
Intervention code [1] 314807 0
Not applicable
Comparator / control treatment
No comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320493 0
Treatment administered as assessed by data-linkage to medical records
Timepoint [1] 320493 0
post discharge and annually for 5 years.
Secondary outcome [1] 371790 0
nil
Timepoint [1] 371790 0
nil

Eligibility
Key inclusion criteria
All children or adults with renal biopsy proven medical renal disease.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not willing to participate in the registry
Inability to obtain informed consent from the parent or guardian
Inability to understand English in the absence of an interpreter

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
not applicable; The study is an observational study on different subset of biopsy proven renal disorders and therefore no power calculations can be made.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/02/2019
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
5000
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14030 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 14031 0
Mackay Base Hospital - Mackay
Recruitment hospital [3] 14032 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [4] 14033 0
Rockhampton Base Hospital - Rockhampton
Recruitment hospital [5] 14108 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [6] 14109 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 14110 0
The Townsville Hospital - Douglas
Recruitment hospital [8] 14112 0
Logan Hospital - Meadowbrook
Recruitment hospital [9] 14113 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [10] 14139 0
Hervey Bay Hospital - Pialba
Recruitment postcode(s) [1] 26820 0
4029 - Herston
Recruitment postcode(s) [2] 26821 0
4740 - Mackay
Recruitment postcode(s) [3] 26822 0
4670 - Bundaberg
Recruitment postcode(s) [4] 26823 0
4700 - Rockhampton
Recruitment postcode(s) [5] 26901 0
4350 - Toowoomba
Recruitment postcode(s) [6] 26902 0
4215 - Southport
Recruitment postcode(s) [7] 26903 0
4814 - Douglas
Recruitment postcode(s) [8] 26905 0
4131 - Meadowbrook
Recruitment postcode(s) [9] 26906 0
4101 - South Brisbane
Recruitment postcode(s) [10] 26951 0
4655 - Pialba

Funding & Sponsors
Funding source category [1] 303095 0
Hospital
Name [1] 303095 0
Royal Brisbane & Women's Hospital
Country [1] 303095 0
Australia
Funding source category [2] 303219 0
University
Name [2] 303219 0
University of Quuensland
Country [2] 303219 0
Australia
Funding source category [3] 303220 0
Government body
Name [3] 303220 0
Pathology Queensland
Country [3] 303220 0
Australia
Funding source category [4] 303221 0
Hospital
Name [4] 303221 0
Hervey Bay Hospital
Country [4] 303221 0
Australia
Funding source category [5] 303222 0
Hospital
Name [5] 303222 0
Logan Hospital
Country [5] 303222 0
Australia
Funding source category [6] 303223 0
Hospital
Name [6] 303223 0
Mackay Base Hospital
Country [6] 303223 0
Australia
Funding source category [7] 303224 0
Hospital
Name [7] 303224 0
Townsville Hospital
Country [7] 303224 0
Australia
Funding source category [8] 303225 0
Hospital
Name [8] 303225 0
Queensland Children Hospital,
Country [8] 303225 0
Australia
Funding source category [9] 303226 0
Hospital
Name [9] 303226 0
Darling Downs Hospital
Country [9] 303226 0
Australia
Funding source category [10] 303227 0
Hospital
Name [10] 303227 0
Rockhampton Hospital
Country [10] 303227 0
Australia
Funding source category [11] 303228 0
Hospital
Name [11] 303228 0
Bundaberg Base Hospital
Country [11] 303228 0
Australia
Funding source category [12] 303229 0
Hospital
Name [12] 303229 0
Gold Coast University Hospital
Country [12] 303229 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Dwarakanathan Ranganathan on behalf of Steering Committee , Queensland Renal Biopsy Registry
Country
Australia
Secondary sponsor category [1] 303155 0
Individual
Name [1] 303155 0
Wendy Hoy
Country [1] 303155 0
Australia
Secondary sponsor category [2] 303233 0
Individual
Name [2] 303233 0
Dr Leo Francis
Country [2] 303233 0
Australia
Other collaborator category [1] 280839 0
Individual
Name [1] 280839 0
Dr Krishan Madhan
Country [1] 280839 0
Australia
Other collaborator category [2] 280840 0
Individual
Name [2] 280840 0
Dr Jeremy Elton Frazier
Country [2] 280840 0
Australia
Other collaborator category [3] 280841 0
Individual
Name [3] 280841 0
Dr Roy Cherian
Country [3] 280841 0
Australia
Other collaborator category [4] 280842 0
Individual
Name [4] 280842 0
Dr Valli Manickam
Country [4] 280842 0
Australia
Other collaborator category [5] 280843 0
Individual
Name [5] 280843 0
Dr Peter Trnka
Country [5] 280843 0
Australia
Other collaborator category [6] 280844 0
Individual
Name [6] 280844 0
Dr Sree Krishna Venuthurupalli
Country [6] 280844 0
Australia
Other collaborator category [7] 280845 0
Individual
Name [7] 280845 0
Dr Zaw Thet
Country [7] 280845 0
Australia
Other collaborator category [8] 280846 0
Individual
Name [8] 280846 0
Dr Clyson Mutatiri
Country [8] 280846 0
Australia
Other collaborator category [9] 280847 0
Individual
Name [9] 280847 0
Dr Murthy Divi
Country [9] 280847 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303639 0
RBWH Ethics committee
Ethics committee address [1] 303639 0
Ethics committee country [1] 303639 0
Australia
Date submitted for ethics approval [1] 303639 0
14/11/2017
Approval date [1] 303639 0
23/01/2018
Ethics approval number [1] 303639 0
HREC/17/QRBW/661
Ethics committee name [2] 303717 0
Children' Health Queensland Hospital and Health Service Human Reseearch Ethics Committee
Ethics committee address [2] 303717 0
Ethics committee country [2] 303717 0
Australia
Date submitted for ethics approval [2] 303717 0
28/03/2018
Approval date [2] 303717 0
24/05/2018
Ethics approval number [2] 303717 0
HREC/18/QRCH/123

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94358 0
A/Prof Dwarakanathan Ranganathan
Address 94358 0
Senior Staff Specialist Royal Brisbane &Women's Hospital Herston ,Qld 4029
Country 94358 0
Australia
Phone 94358 0
+61 07 36468576
Fax 94358 0
+61 07 36468572
Email 94358 0
dwarakanathan.ranganathan@health.qld.gov.au
Contact person for public queries
Name 94359 0
Dwarakanathan Ranganathan
Address 94359 0
Senior Staff Specialist Royal Brisbane &Women's Hospital Herston ,Qld 4029
Country 94359 0
Australia
Phone 94359 0
+61 07 36468576
Fax 94359 0
+61 07 36468572
Email 94359 0
dwarakanathan.ranganathan@health.qld.gov.au
Contact person for scientific queries
Name 94360 0
Dwarakanathan Ranganathan
Address 94360 0
Senior Staff Specialist Royal Brisbane &Women's Hospital Herston ,Qld 4029
Country 94360 0
Australia
Phone 94360 0
+61 07 36468576
Fax 94360 0
+61 07 36468572
Email 94360 0
dwarakanathan.ranganathan@health.qld.gov.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• At a minimum of annual intervals during the study, results will be converted into a report of de-identified data for user groups, participating renal units, and collaborators, which will include, but is not limited to, Queensland Health

Conditions for requesting access:
• -

What individual participant data might be shared?
• At a minimum of annual intervals during the study, results will be converted into a report of de-identified data for user groups, participating renal units, and collaborators, which will include, but is not limited to, Queensland Health

What types of analyses could be done with individual participant data?
• Descriptive statistics and frequency distributions will be done for continuous and categorical variables respectively. The association between renal function and risk factors [e.g. age, sex, time taken for referral, renal function on presentation, will be calculated and analysed by bi-variate [unadjusted] and multivariate analysis [adjusted].

When can requests for individual participant data be made (start and end dates)?
From:
Start Date: January 2019
End Date: December 2026; will be ongoing as it is a registry

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Results will be converted to reports

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2400Ethical approval    Study-related document.pdf
2578Ethical approval    Study-related document.pdf
2579Study protocol    Study-related document.pdf
2597Informed consent form    Study-related document.pdf



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.