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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04389827




Registration number
NCT04389827
Ethics application status
Date submitted
4/05/2020
Date registered
15/05/2020

Titles & IDs
Public title
Global Kidney Patient Trials Network
Scientific title
Global Kidney Patient Trials Network
Secondary ID [1] 0 0
GKPTN2019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Diseases 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Incident & Prevalent Patients - Incident and prevalent patients diagnosed with a kidney disease at participating centres
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
estimated Glomerular Filtration Rate (eGFR)
Timepoint [1] 0 0
Collected Six-Monthly (minimum)
Primary outcome [2] 0 0
Albuminuria
Timepoint [2] 0 0
Collected Six-Monthly (minimum)

Eligibility
Key inclusion criteria
1. Documented diagnosis of primary kidney disease
2. Regular visits (at least 6 monthly) with a physician at a participating site
3. eGFR > 15 ml/min/1.73m2
4. = 2 years of age
5. Willing and able to sign informed consent
6. Willing to be approached about participation in interventional research studies
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Life-expectancy of less than 6 months
2. Currently receiving renal replacement therapy or planned to start in the next 6 months
3. Currently participating in a clinical trial involving investigational medicinal product (exception is participation in studies implemented through the GKPTN)

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
5/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2030
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The George Institute - Sydney
Recruitment postcode(s) [1] 0 0
2042 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The George Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
George Clinical Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Hiddo Lambers Heerspink
Address 0 0
The George Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
FanHan Hsu
Address 0 0
Country 0 0
Phone 0 0
+61 2 8052 4511
Fax 0 0
Email 0 0
gkptn@georgeinstitute.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The current plan is that only aggregate data will be shared for research purposes. Individual participant data would only be reviewed in incidental findings and only be discussed with the participant in question.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04389827