Evaluation of the Integrated Home Dialysis Model

Completed

• Conditions: Kidney Failure, Chronic
• Interventions: Procedure: Home hemodialysis; Procedure: Peritoneal dialysis

• Registration Number: NCT02278159
• Lead Sponsor: Princess Alexandra Hospital, Brisbane, Australia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2014-06-19
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-27
• Last Update Submitted: 2014-10-27
• Study First Posted: 2014-10-29
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Home hemodialysis only	Home hemodialysis	Patient on HHD 90 days after renal replacement therapy initiation and not transferred to PD
HHD and PD	Peritoneal dialysis	Patient on HHD after RRT initiation and transferred to PD less than 90 days after HHD failure
HHD and PD	Home hemodialysis	Patient on HHD after RRT initiation and transferred to PD less than 90 days after HHD failure
PD and HHD	Peritoneal dialysis	Patient on PD 90 days after RRT initiation and transferred to HHD less than 90 days after PD failure
Peritoneal dialysis only	Peritoneal dialysis	Patient on PD modality 90 days after renal replacement therapy initiation and not transferred to HHD
PD and HHD	Home hemodialysis	Patient on PD 90 days after RRT initiation and transferred to HHD less than 90 days after PD failure

Primary Outcome Measures

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

Secondary Outcome Measures

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