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PINOT Follow-up Study in End-stage Kidney Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01768624
First Posted: January 15, 2013
Last Update Posted: October 26, 2016
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.
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
  Purpose

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 Intervention
Chronic Kidney Disease Procedure: dialysis, kidney transplant

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 721
Study Start Date: October 2012
Study Completion Date: September 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
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
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
Principal Investigator: Rachael L Morton, PhD University of Sydney