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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05434325




Registration number
NCT05434325
Ethics application status
Date submitted
14/06/2022
Date registered
28/06/2022
Date last updated
12/01/2023

Titles & IDs
Public title
TESTING -ON Post-Trial ObservatioNal Cohort Study
Scientific title
Therapeutic Evaluation of STeroids in IgA Nephropathy Global - Post-Trial ObservatioNal Cohort Study
Secondary ID [1] 0 0
TESTING-ON
Universal Trial Number (UTN)
Trial acronym
TESTING-ON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IgA Nephropathy 0 0
ESRD 0 0
Glomerulonephritis 0 0
Kidney Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
TESTING Particpants - All participants who were successfully randomised to the TESTING study who are still alive and have not reached kidney failure requiring dialysis.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary AIM
Timepoint [1] 0 0
Through study completion, an average of 1 year
Secondary outcome [1] 0 0
Secondary Aims
Timepoint [1] 0 0
Through study completion, an average of 1 year
Secondary outcome [2] 0 0
Secondary Aims
Timepoint [2] 0 0
Through Study completion, an average of 1 year
Secondary outcome [3] 0 0
Secondary Aims
Timepoint [3] 0 0
Through Study Completion, an average of 1 year
Secondary outcome [4] 0 0
Secondary Aims
Timepoint [4] 0 0
Through Study Completion, an average of 1 year
Secondary outcome [5] 0 0
Secondary Aims
Timepoint [5] 0 0
Through Study Complication an average of 1 Year
Secondary outcome [6] 0 0
Secondary Aim
Timepoint [6] 0 0
Through Study Completion an average of 1 year

Eligibility
Key inclusion criteria
1) Only participants who were randomised into the TESTING trial
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

1. Participants who have reached kidney failure requiring maintenance dialysis or kidney
transplantation during the TESTING trial

2. Participants who died during the TESTING trial

3. Participants who had withdrawn their consent during the TESTING trial

4. Participants who are unable to provide consent for some other reason

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
366
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Guangdong
Country [7] 0 0
China
State/province [7] 0 0
Hebei
Country [8] 0 0
China
State/province [8] 0 0
Henan
Country [9] 0 0
China
State/province [9] 0 0
Hubei
Country [10] 0 0
China
State/province [10] 0 0
Inner Mongolia
Country [11] 0 0
China
State/province [11] 0 0
Jiangsu
Country [12] 0 0
China
State/province [12] 0 0
Jilin
Country [13] 0 0
China
State/province [13] 0 0
Liaoning
Country [14] 0 0
China
State/province [14] 0 0
Shandong
Country [15] 0 0
China
State/province [15] 0 0
Shanxi
Country [16] 0 0
China
State/province [16] 0 0
Sichuan
Country [17] 0 0
China
State/province [17] 0 0
Zhejiang
Country [18] 0 0
China
State/province [18] 0 0
Chongqing
Country [19] 0 0
China
State/province [19] 0 0
Shanghai
Country [20] 0 0
Hong Kong
State/province [20] 0 0
Kowloon
Country [21] 0 0
India
State/province [21] 0 0
Andhra Pradesh
Country [22] 0 0
India
State/province [22] 0 0
Kerala
Country [23] 0 0
India
State/province [23] 0 0
Punjab
Country [24] 0 0
India
State/province [24] 0 0
Tamil Nadu
Country [25] 0 0
Malaysia
State/province [25] 0 0
Johor
Country [26] 0 0
Malaysia
State/province [26] 0 0
Kulala Lumpur
Country [27] 0 0
Malaysia
State/province [27] 0 0
Negri Seremban
Country [28] 0 0
Malaysia
State/province [28] 0 0
Perak
Country [29] 0 0
Malaysia
State/province [29] 0 0
Samarahan
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peking University Institute of Nephrology
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary aim of this study is to extend follow up of TESTING study participants and to
assess the long-term effects of a 6-9-month course of oral methylprednisolone on End Stage
Kidney Disease (ESKD), according to dose (full-dose vs reduced-dose), ethnicity (Chinese vs
other) and kidney function (eGFR above and below 60 mL/min/1.73m2).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05434325
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hong Zhang, Prof
Address 0 0
Peking University Institute of Nephrology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Rebecca Anderson
Address 0 0
Country 0 0
Phone 0 0
+61401401440
Fax 0 0
Email 0 0
randerson@georgeinstitute.org.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05434325