Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01298115




Registration number
NCT01298115
Ethics application status
Date submitted
15/02/2011
Date registered
17/02/2011
Date last updated
17/02/2011

Titles & IDs
Public title
Patient INformation About Options for Treatment - PINOT
Scientific title
Patient Information About Options for Treatment of Stage 5 Chronic Kidney Disease
Secondary ID [1] 0 0
RM-1/09
Universal Trial Number (UTN)
Trial acronym
PINOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Stage 5 chronic kidney disease - Incident patients commencing renal replacement therapy or conservative care
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of incident Stage 5 CKD patients who receive information about their treatment options prior to commencing treatment
Timepoint [1] 0 0
Time prior to commencement of treatment. eg. 3 months
Secondary outcome [1] 0 0
Stage of CKD (based on eGFR) when information about treatment options is first given
Timepoint [1] 0 0
one time point prior to commencement of treatment
Secondary outcome [2] 0 0
Patient and unit characteristics associated with commencing renal replacement therapy versus conservative care
Timepoint [2] 0 0
One time point based on commencement date of first treatment

Eligibility
Key inclusion criteria
* Patients attending Australian adult or pediatric renal units
* Patients with Stage 5 chronic kidney disease commencing dialysis or having a pre-emptive transplant or with decision made for conservative care and eGFR < 15ml/min/1.73m2 between 1st July and 30th September 2009
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with acute kidney injury not requiring chronic renal replacement therapy
* Patients with a failing kidney transplant returning to dialysis

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2010
Sample size
Target
Accrual to date
Final
721
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Sydney South West Area Health Service
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
South West Sydney Local Health District
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kirsten Howard, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Morton RL, Howard K, Webster AC, Snelling P. Patie... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01298115