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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

Tracking Information
First Submitted Date January 11, 2013
First Posted Date January 15, 2013
Last Update Posted Date October 26, 2016
Study Start Date October 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2013)
The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis. [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 14, 2013)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PINOT Follow-up Study in End-stage Kidney Disease
Official Title Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Chronic Kidney Disease
Intervention Procedure: dialysis, kidney transplant
Study Groups/Cohorts 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
Intervention: Procedure: dialysis, kidney transplant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 14, 2013)
721
Original Estimated Enrollment Same as current
Actual Study Completion Date September 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01768624
Other Study ID Numbers RM-1/12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Sydney
Study Sponsor University of Sydney
Collaborators
  • 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
PRS Account University of Sydney
Verification Date October 2016