Trial Review

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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
Address
Associate Professor Dwarakanathan Ranganathan
Coordinating Principal Investigator,
Collaborative Group : Queensland Renal Biopsy Steering Committee
Royal Brisbane & Women's Hospital, Butterfield Street, Herston, Qld, 4029
Country
Australia
Secondary sponsor category [1] 303155 0
Individual
Name [1] 303155 0
Wendy Hoy
Address [1] 303155 0
Principal Investigator,
Centre for Chronic Diseases , University of Queensland
Level 8, Health Sciences Center, Herston Road, Herston, Qld,4029, Australia
Country [1] 303155 0
Australia
Secondary sponsor category [2] 303233 0
Individual
Name [2] 303233 0
Dr Leo Francis
Address [2] 303233 0
Senior Staff Pathologist,
Pathology Queensland,
Building 7 , Herston Road, Herston , Qld, 4029
Country [2] 303233 0
Australia
Other collaborator category [1] 280839 0
Individual
Name [1] 280839 0
Dr Krishan Madhan
Address [1] 280839 0
Director, Department of Renal Medicin
Harvey Bay Hospital,
Urraween Rd, Pialba QLD 4655
Country [1] 280839 0
Australia
Other collaborator category [2] 280840 0
Individual
Name [2] 280840 0
Dr Jeremy Elton Frazier
Address [2] 280840 0
Staff Specialist
Logan Hospital,
Armstrong Rd &, Loganlea Rd, Meadowbrook QLD 4131Logan
Country [2] 280840 0
Australia
Other collaborator category [3] 280841 0
Individual
Name [3] 280841 0
Dr Roy Cherian
Address [3] 280841 0
Director Renal Medicine
Mackay Base Hospital,
475 Bridge Rd, Mackay,QLD 4740
Country [3] 280841 0
Australia
Other collaborator category [4] 280842 0
Individual
Name [4] 280842 0
Dr Valli Manickam
Address [4] 280842 0
Senior Staff Nephrologist
Townsville Hospital ,
100 Angus Smith Dr, Douglas, QLD, 4814
Country [4] 280842 0
Australia
Other collaborator category [5] 280843 0
Individual
Name [5] 280843 0
Dr Peter Trnka
Address [5] 280843 0
Director of Renal Medicine
Queensland Children Hospital,
501, Stanley Street
South Brisbane, Qld, 4101
Country [5] 280843 0
Australia
Other collaborator category [6] 280844 0
Individual
Name [6] 280844 0
Dr Sree Krishna Venuthurupalli
Address [6] 280844 0
Senior Staff Nephrologist
Darling Downs Hospital,
Tor St & Hogg St, Toowoomba City QLD 4350
Country [6] 280844 0
Australia
Other collaborator category [7] 280845 0
Individual
Name [7] 280845 0
Dr Zaw Thet
Address [7] 280845 0
Member, Queensland Renal Biopsy Steering Committee
Staff Specialist
Rockhampton Hospital
Canning St, Rockhampton QLD 4700
Country [7] 280845 0
Australia
Other collaborator category [8] 280846 0
Individual
Name [8] 280846 0
Dr Clyson Mutatiri
Address [8] 280846 0
Director
Department of Nephrology
Bundaberg Base Hospital
Bourborg St, Bundaberg Central , QLD, 4670
Country [8] 280846 0
Australia
Other collaborator category [9] 280847 0
Individual
Name [9] 280847 0
Dr Murthy Divi
Address [9] 280847 0

Director, Department of Nephrology,
Gold Coast University Hospital,
1,Hospital Blvd, south Port, QLD, 4215
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
Royal Brisbane & Women's Hospital
Building 7, RBWH campus,
Herston Road
Herston, Qld, 4029,
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
Level 7, Center for Children's Health Research ,
62, Graham Street, South Brisbane, Qld, 4101
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
Registry of patients with biopsy-proven renal disorders enabled by a collaboration of the State Wide Clinical Renal Network , Renal Physicians from Hospital and Health Services across Pathology Queensland and CKD.QLD,The University of Queensland and governed by a steering committee.
The principal aim of the Registry is to improve patient care and outcomes. The Registry will do this by profiling renal biopsy proven disorders in Queensland which will facilitate early recognition, benchmark management to best practice, and provide a platform to validate new care strategies.
Specific objectives include:
1.Development of a prospective collection of clinical, laboratory, pathology, treatment and outcome data of patients with biopsy proven medical renal disease
2.Consolidation of data into a collated data set [Registry]
3.Evaluation of patient data to identify and facilitate improved clinical care and management
4.Support clinical research
5.Identification and development of health policies targeting patients with biopsy proven renal disorders
6.Develop links and collaborations with other registries nationally and internationally
Trial website
No website Yet
Trial related presentations / publications
NIl
Public notes
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, The University of Queensland, the . In addition, outcomes will be published in academic journals and on the QRBR website: www.QRBR.org, for professional and patient information and dissemination.
Reports of the units will be publicly displayed if there is a minimal collection of the data of at least 80% of the patients. Analyses of this data will require permission from the steering committee of the renal biopsy registry.

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
[email protected]
Contact person for public queries
Name 94359 0
A/Prof 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
[email protected]
Contact person for scientific queries
Name 94360 0
A/Prof 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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will 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
When will data be available (start and end dates)?
Start Date: January 2019
End Date: December 2026; will be ongoing as it is a registry
Available to whom?
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
Available for what types of analyses?
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].
How or where can data be obtained?
Results will be converted to reports


What supporting documents are/will be available?




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.