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Evaluation of the Integrated Home Dialysis Model

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02278159
Enrollment
11600
Registered
2014-10-29
Start date
2000-01-31
Completion date
2012-12-31
Last updated
2014-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

end-stage kidney disease, peritoneal dialysis, home hemodialysis, technique survival, patient survival

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.

Interventions

PROCEDUREPeritoneal dialysis
PROCEDUREHome hemodialysis

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Princess Alexandra Hospital, Brisbane, Australia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Home dialysis survivalSurvival analysis; specific analysis at 5 years after dialysis initiationTime to first patient death or home dialysis technique failure for each home dialysis modalities, censored for transplantation and loss to follow-up

Secondary

MeasureTime frameDescription
Patient survival, censored for technique failureSurvival analysis, specific analysis at 1,2 5 years after dialysis initiationPatient survival on each specific home dialysis modality, censored for technique failure, transplantation and loss to follow-up
Home technique survival, censored for deathsurvival analysis, specific analysis at 1,2 5 years after dialysis initiationHome dialysis technique survival for each home dialysis modality, censored for patient death, transplantation and loss to follow-up

Other

MeasureTime frameDescription
Home dialysis survival, case-control analysissurvival analysis, specific analysis at 1,2 5 years after dialysis initiationCase-control analysis will be performed in order to address immortal bias in patients classified in the switchingcategories (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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026