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OpenTrials
Completed

NCT Number: NCT02278159

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.

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peritoneal dialysis

Procedure

Home hemodialysis

Procedure

Primary outcomes

  1. Home dialysis survival

    Time frame: 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 outcomes

  1. Patient survival, censored for technique failure

    Time frame: 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

  2. Home technique survival, censored for death

    Time frame: 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

Other outcomes

  1. Home dialysis survival, case-control analysis

    Time frame: survival analysis, specific analysis at 1,2 5 years after dialysis initiation

    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).

Sponsors and collaborators

Lead sponsor

Princess Alexandra Hospital, Brisbane, Australia

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Important dates

Study start
2000
Primary completion
2012
Study completion
2012
First posted
Oct 29, 2014
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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