Evaluation of the Integrated Home Dialysis Model

October 27, 2014 updated by: David Johnson, Princess Alexandra Hospital, Brisbane, Australia
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Survival analysis; specific analysis at 5 years after dialysis initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Survival analysis, specific analysis at 1,2 5 years after dialysis initiation
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
survival analysis, specific analysis at 1,2 5 years after dialysis initiation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
survival analysis, specific analysis at 1,2 5 years after dialysis initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Princess Alexandra Hospital, Brisbane, Australia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2000

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANZ41367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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