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PINOT Follow-up Study in End-stage Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01768624
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : October 26, 2016
Sponsor:
Collaborators:
National Health and Medical Research Council, Australia
Sydney South West Area Health Service
South West Sydney Local Health District
Kidney Health Australia
Information provided by (Responsible Party):
University of Sydney

Study Description
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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.

Condition or disease Intervention/treatment
Chronic Kidney Disease Procedure: dialysis, kidney transplant

Detailed Description:

The secondary aims of the follow-up study include:

(i) To assess the primary reasons patients did not transition to home dialysis, in the planned home dialysis group.

(ii)To compare 3 and 5 year survival rates among patients who commenced conservative care and patients who commenced renal replacement therapy.

(iii) To assess the types of dialysis utilisation over a 5 year time period among the total cohort of patients.

(iv)To determine how renal palliative care services were engaged for conservative care patients, and document the patient's place of death (i.e. hospital, hospice, home with community palliative care).

Study Design
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Study Type : Observational
Actual Enrollment : 721 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.
Study Start Date : October 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Procedure: dialysis, kidney transplant


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices
Criteria

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

Exclusion Criteria:

  • Patients returning to dialysis after a failed transplant,
  • Patients with acute renal failure
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01768624


Locations
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Australia, New South Wales
University of Sydney
Sydney, New South Wales, Australia, 2006
United Kingdom
University of Oxford
Headington, Oxfordshire, United Kingdom, OX38QY
Sponsors and Collaborators
University of Sydney
National Health and Medical Research Council, Australia
Sydney South West Area Health Service
South West Sydney Local Health District
Kidney Health Australia
Investigators
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Principal Investigator: Rachael L Morton, PhD University of Sydney
More Information
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Publications of Results:

Other Publications:

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Responsible Party: University of Sydney
ClinicalTrials.gov Identifier: NCT01768624    
Other Study ID Numbers: RM-1/12
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016
Keywords provided by University of Sydney:
chronic kidney disease
dialysis
pre dialysis education
transplantation
conservative care
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency