Kidney Failure, ChronicNCT02278159
Evaluation of the Integrated Home Dialysis Model
An observational study of Kidney Failure, Chronic, run by Princess Alexandra Hospital, Brisbane, Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Peritoneal dialysis and Home hemodialysis
- Type of treatment
- Surgery or procedure
- How many people
- 11,600 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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]
Who may be able to join
- Patients with PD/HHD 90 days after RRT initiation between January 1, 2000 and December 31, 2012 reported in ANZDATA
- ≥ 18 years
Who cannot join
- Less than 90 days of dialysis
- < 18 years
- Patients transferred to Australia/New Zealand after initiation of dialysis in another country
About this study
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.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Peritoneal dialysis, Home hemodialysis
- Keywords
- end-stage kidney disease, peritoneal dialysis, home hemodialysis, technique survival, patient survival
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal dialysisProcedure or surgery
Home hemodialysisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal dialysis only | Patient on PD modality 90 days after renal replacement therapy initiation and not transferred to HHD Receives: Procedure: Peritoneal dialysis | |
| Home hemodialysis only | Patient on HHD 90 days after renal replacement therapy initiation and not transferred to PD Receives: 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 Receives: 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 Receives: Procedure: Peritoneal dialysis; Procedure: Home hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Survival analysis; specific analysis at 5 years after dialysis initiation
Secondary outcomes (2)
Patient survival, censored for technique failure
Patient survival on each specific home dialysis modality, censored for technique failure, transplantation and loss to follow-up
Measured: Survival analysis, specific analysis at 1,2 5 years after dialysis initiation
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
Measured: survival analysis, specific analysis at 1,2 5 years after dialysis initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startJan 2000
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Princess Alexandra Hospital, Brisbane, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, David Johnson, Princess Alexandra Hospital, Brisbane, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278159
- Sponsor's protocol ID
- ANZ41367
- Status last verified
- Oct 2014
- First submitted
- 19 Jun 2014
- Last updated
- 29 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Integrated Home Dialysis Model
- ClinicalTrials.gov ID
- NCT02278159
- Acronym / sponsor ID
- ANZ41367
- Conditions
- Kidney Failure, Chronic
- Keywords
- end-stage kidney disease, peritoneal dialysis, home hemodialysis, technique survival, patient survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,600 participants (actual)
- Lead sponsor
- Princess Alexandra Hospital, Brisbane, AustraliaUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jan 2000
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis only | – | Procedure: Peritoneal dialysisPatient on PD modality 90 days after renal replacement therapy initiation and not transferred to HHD |
| Home hemodialysis only | – | Procedure: Home hemodialysisPatient on HHD 90 days after renal replacement therapy initiation and not transferred to PD |
| PD and HHD | – | Procedure: Peritoneal dialysis, Procedure: Home hemodialysisPatient on PD 90 days after RRT initiation and transferred to HHD less than 90 days after PD failure |
| HHD and PD | – | Procedure: Peritoneal dialysis, Procedure: Home hemodialysisPatient on HHD after RRT initiation and transferred to PD less than 90 days after HHD failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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]
Key inclusion criteria (2 listed)
- Patients with PD/HHD 90 days after RRT initiation between January 1, 2000 and December 31, 2012 reported in ANZDATA
- ≥ 18 years
Key exclusion criteria (3 listed)
- Less than 90 days of dialysis
- < 18 years
- Patients transferred to Australia/New Zealand after initiation of dialysis in another country
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal dialysis | Procedure or surgery | HHD and PD, PD and HHD, Peritoneal dialysis only |
| Home hemodialysis | Procedure or surgery | HHD and PD, Home hemodialysis only, PD and HHD |
Primary outcome
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
2 secondary outcomes
Patient survival, censored for technique failure
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by Princess Alexandra Hospital, Brisbane, Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home dialysis survival (time frame: Survival analysis; specific analysis at 5 years after dialysis initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.