Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001429145
Ethics application status
Approved
Date submitted
24/07/2019
Date registered
15/10/2019
Date last updated
3/04/2024
Date data sharing statement initially provided
15/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Glomerular Disease Registry
Scientific title
Glomerular Disease Registry
Secondary ID [1] 298832 0
None
Universal Trial Number (UTN)
Trial acronym
GRIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glomerular Disease 313786 0
Condition category
Condition code
Renal and Urogenital 312192 312192 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
10
Target follow-up type
Years
Description of intervention(s) / exposure
We will collect health data and blood samples with patient consent on patients with glomerular disease. We intend that the study will continue recruitment for a minimum of 10 years. We will also consent patients for interest in participating in clinical trials.
Intervention code [1] 315099 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320822 0
To accurately ascertain the disease burden of glomerular diseases across study sites measured by the number of participants entered into the registry.
Timepoint [1] 320822 0
We will collect data through the patients physician on a yearly basis. We intend to continue follow up for a minimum of 10 years.
Secondary outcome [1] 372955 0
to assess willingness to participate in clinical trials measured by the number of particiaptns who consent to be contacted for participation in clinical trials.
Timepoint [1] 372955 0
We will collect health data on patients through their treating physician on a yearly basis for 10 years
Secondary outcome [2] 375056 0
Generate a repository of blood samples
Timepoint [2] 375056 0
at time of entry into study only

Eligibility
Key inclusion criteria
All patients with a biopsy confirmed diagnosis of glomerulonephritis.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NIL

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data will be checked for validity and accuracy on a periodic basis. An annual report reporting on the demographic details (age, gender, current medication, diagnosis) and number of patients enrolled in the registry will be provided to all sites participating in the study.
Descriptive statistics will be used to describe the cohort but the primary purpose of the registry is not data analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/03/2020
Actual
16/03/2020
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
15/09/2029
Actual
Sample size
Target
300
Accrual to date
198
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 14302 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 14303 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 14304 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 14305 0
St George Hospital - Kogarah
Recruitment hospital [5] 14306 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 14307 0
Nepean Hospital - Kingswood
Recruitment hospital [7] 14308 0
Westmead Hospital - Westmead
Recruitment hospital [8] 21805 0
Canterbury Hospital - Campsie
Recruitment hospital [9] 21806 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 27300 0
2031 - Randwick
Recruitment postcode(s) [2] 27301 0
2170 - Liverpool
Recruitment postcode(s) [3] 27302 0
2139 - Concord
Recruitment postcode(s) [4] 27303 0
2217 - Kogarah
Recruitment postcode(s) [5] 27304 0
2065 - St Leonards
Recruitment postcode(s) [6] 27305 0
2747 - Kingswood
Recruitment postcode(s) [7] 27306 0
2145 - Westmead
Recruitment postcode(s) [8] 36863 0
2194 - Campsie
Recruitment postcode(s) [9] 36864 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 303381 0
Other
Name [1] 303381 0
The George Institute for Global Health
Country [1] 303381 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Three International Towers, Level 18/300 Barangaroo Ave, Barangaroo NSW 2000
Country
Australia
Secondary sponsor category [1] 303417 0
None
Name [1] 303417 0
Address [1] 303417 0
Country [1] 303417 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303913 0
Concord Repatriation General Hospital Ethics Committee
Ethics committee address [1] 303913 0
Ground Floor - Building 20, Concord Repatriation General Hospital, Hospital Rd, Concord NSW 2139
Ethics committee country [1] 303913 0
Australia
Date submitted for ethics approval [1] 303913 0
23/11/2018
Approval date [1] 303913 0
29/04/2019
Ethics approval number [1] 303913 0
2019/ETH11937

Summary
Brief summary
Glomerulonephritis are an important cause of significant symptoms and end stage renal disease. There are no established registries that study these rare causes of kidney disease in a systematic fashion in Australia. This prospective project will enrol all patients with biopsy confirmed Glomerulonephritis attending renal clinics at the participating hospitals to develop a repository of patients with glomerular diseases in a systematic fashion to understand clinical outcomes better and to easily identify and recruit patients for future clinical trials. We also aim to collect biological samples with patient consent to allow testing and discovery of potential genetic markers and novel therapeutic agents.
Data will be stored electronically on the servers of The George Institute for Global Health
Trial website
Nil
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 95226 0
Dr Sradha Kotwal
Address 95226 0
The George Institute for Global Health,
Level 5, 1 King Street
Newtown, Sydney NSW 2042
Country 95226 0
Australia
Phone 95226 0
+61 2 93824473
Fax 95226 0
Email 95226 0
[email protected]
Contact person for public queries
Name 95227 0
Dr Sradha Kotwal
Address 95227 0
The George Institute for Global Health,
Level 5, 1 King Street
Newtown, Sydney NSW 2042
Country 95227 0
Australia
Phone 95227 0
+61 2 93824473
Fax 95227 0
Email 95227 0
[email protected]
Contact person for scientific queries
Name 95228 0
Dr Sradha Kotwal
Address 95228 0
The George Institute for Global Health,
Level 5, 1 King Street
Newtown, Sydney NSW 2042
Country 95228 0
Australia
Phone 95228 0
+61 2 93824473
Fax 95228 0
Email 95228 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is not a trial.


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.