Evaluation of the Integrated Home Dialysis Model

The purpose of this study is to evaluate which home dialysis modality pattern (home hemodialysis [HHD], peritoneal dialysis [PD] or a combination of both, e.g. PD and then HHD) allows for the longest home dialysis survival, as defined by the time dialysed in a home environment. The investigators hypothesize that patients transferred from one home modality to another will have a longer home dialysis survival compared to patients treated only with PD or HHD.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Procedure: Peritoneal dialysis; Procedure: Home hemodialysis

• Study Type: Observational
• Enrollment (Actual): 11600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with home dialysis as the first renal replacement therapy [RRT] modality (defined by the dialysis modality at 90 days) in Australia and New Zealand as reported in Australia and New Zealand Dialysis and Transplant Registry [ANZDATA]

Description

Inclusion Criteria:

• Patients with PD/HHD 90 days after RRT initiation between January 1, 2000 and December 31, 2012 reported in ANZDATA
• ≥ 18 years

Exclusion Criteria:

• Less than 90 days of dialysis
• < 18 years
• Patients transferred to Australia/New Zealand after initiation of dialysis in another country

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peritoneal dialysis only; Patient on PD modality 90 days after renal replacement therapy initiation and not transferred to HHD	Procedure: Peritoneal dialysis
Home hemodialysis only; Patient on HHD 90 days after renal replacement therapy initiation and not transferred to PD	Procedure: Home hemodialysis
PD and HHD; Patient on PD 90 days after RRT initiation and transferred to HHD less than 90 days after PD failure	Procedure: Peritoneal dialysis; Procedure: Home hemodialysis
HHD and PD; Patient on HHD after RRT initiation and transferred to PD less than 90 days after HHD failure	Procedure: Peritoneal dialysis; Procedure: Home hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home dialysis survival	Time to first patient death or home dialysis technique failure for each home dialysis modalities, censored for transplantation and loss to follow-up	Survival analysis; specific analysis at 5 years after dialysis initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient survival, censored for technique failure	Patient survival on each specific home dialysis modality, censored for technique failure, transplantation and loss to follow-up	Survival analysis, specific analysis at 1,2 5 years after dialysis initiation
Home technique survival, censored for death	Home dialysis technique survival for each home dialysis modality, censored for patient death, transplantation and loss to follow-up	survival analysis, specific analysis at 1,2 5 years after dialysis initiation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home dialysis survival, case-control analysis	Case-control analysis will be performed in order to address immortal bias in patients classified in the "switching"categories (PD-HHD or HHD-PD). Since we expect the HHD-PD group to be small, this analysis will be performed only with the 3 other groups (PD-HHD, PD only and HHD only). Patients treated successively with PD and HHD (cases) will be matched (by age and diabetes status) to patient treated with PD only and HHD only (controls).	survival analysis, specific analysis at 1,2 5 years after dialysis initiation

Collaborators and Investigators

• Sponsor: Princess Alexandra Hospital, Brisbane, Australia
• Collaborators: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: June 19, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Estimate): October 29, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: home hemodialysis; peritoneal dialysis; end-stage kidney disease; patient survival; technique survival
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: ANZ41367