Evaluation of the Integrated Home Dialysis Model

Kidney Failure, Chronic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278159
• Other study ID #: ANZ41367
• Status: Completed
• Phase: N/A
• First received: June 19, 2014
• Last updated: October 27, 2014
• Start date: January 2000
• Est. completion date: December 2012

Study information

• Verified date: October 2014
• Source: Princess Alexandra Hospital, Brisbane, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11600
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Procedure:
• Peritoneal dialysis

• Home hemodialysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Princess Alexandra Hospital, Brisbane, Australia	Baxter Healthcare Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No