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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01768624




Registration number
NCT01768624
Ethics application status
Date submitted
11/01/2013
Date registered
15/01/2013
Date last updated
26/10/2016

Titles & IDs
Public title
PINOT Follow-up Study in End-stage Kidney Disease
Scientific title
Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.
Secondary ID [1] 0 0
RM-1/12
Universal Trial Number (UTN)
Trial acronym
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 - Patients receiving home hemodialysis Patients receiving home peritoneal dialysis Patients receiving center-based hemodialysis Patients who had a pre-emptive kidney transplant Patients who planned for renal conservative care
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
The proportion of patients who commence dialysis, or have a time-limited trial of dialysis within 3 and 5 years, after a confirmed plan for conservative care.
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion criteria
* Adults and children with end stage kidney disease (eGFR <15 ml/min) who commenced renal replacement therapy or conservative care in Australia between July and September 2009
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients returning to dialysis after a failed transplant,
* Patients with acute renal failure

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
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
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Oxfordshire

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
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Kidney Health Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that:

(i)Made the transition to home dialysis, after an initial start on center-based dialysis.

(ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed plans for conservative care.

The hypotheses to be tested in the PINOT follow-up study are:

1. 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not commence home dialysis within 3 years, and instead remain on centre-based haemodialysis; and,
2. less than 15% of stage 5 chronic kidney disease patients who plan for conservative care commence dialysis within 3 years.
Trial website
https://clinicaltrials.gov/study/NCT01768624
Trial related presentations / publications
Morton RL, Howard K, Webster AC, Snelling P. Patient INformation about Options for Treatment (PINOT): a prospective national study of information given to incident CKD Stage 5 patients. Nephrol Dial Transplant. 2011 Apr;26(4):1266-74. doi: 10.1093/ndt/gfq555. Epub 2010 Sep 6.
Morton RL, Turner RM, Howard K, Snelling P, Webster AC. Patients who plan for conservative care rather than dialysis: a national observational study in Australia. Am J Kidney Dis. 2012 Mar;59(3):419-27. doi: 10.1053/j.ajkd.2011.08.024. Epub 2011 Oct 20.
Morton RL, Webster AC, McGeechan K, Howard K, Murtagh FEM, Gray NA, Kerr PG, Germain MJ, Snelling P. Conservative Management and End-of-Life Care in an Australian Cohort with ESRD. Clin J Am Soc Nephrol. 2016 Dec 7;11(12):2195-2203. doi: 10.2215/CJN.11861115. Epub 2016 Oct 3.
Public notes

Contacts
Principal investigator
Name 0 0
Rachael L Morton, 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01768624