PINOT Follow-up Study in End-stage Kidney Disease

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Procedure: dialysis, kidney transplant

• Registration Number: NCT01768624
• Lead Sponsor: University of Sydney

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 Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-15
• Primary Completion: 2015-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 721

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stage 5 chronic kidney disease	dialysis, kidney transplant	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

Primary Outcome Measures

Name	Time	Method
The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis.	5 years

Secondary Outcome Measures

Name	Time	Method
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.	5 years

Trial Locations

Locations (2)

University of Sydney; 🇦🇺 Sydney, New South Wales, Australia

University of Oxford; 🇬🇧 Headington, Oxfordshire, United Kingdom