Chronic Kidney DiseaseNCT01768624
PINOT Follow-up Study in End-stage Kidney Disease
An observational study of Chronic Kidney Disease, run by University of Sydney at 2 sites in 2 countries.
Trial summary
The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that: (i)Made the transition to home dialysis, after an initial start on center-based dialysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- dialysis, kidney transplant
- Type of treatment
- Surgery or procedure
- How many people
- 721 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2012to Sep 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices
Who may be able to join
- Adults and children with end stage kidney disease (eGFR <15 ml/min) who commenced renal replacement therapy or conservative care in Australia between July and September 2009
Who cannot join
- Patients returning to dialysis after a failed transplant,
- Patients with acute renal failure
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
University of Oxford
Headington, Oxfordshire, OX38QY
About this study
Official title: Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.
The primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that:
(i)Made the transition to home dialysis, after an initial start on center-based dialysis.
Read more
(ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed plans for conservative care.
The hypotheses to be tested in the PINOT follow-up study are:
- 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not commence home dialysis within 3 years, and instead remain on centre-based haemodialysis; and,
- less than 15% of stage 5 chronic kidney disease patients who plan for conservative care commence dialysis within 3 years.
Read the detailed description
The secondary aims of the follow-up study include:
(i) To assess the primary reasons patients did not transition to home dialysis, in the planned home dialysis group.
(ii)To compare 3 and 5 year survival rates among patients who commenced conservative care and patients who commenced renal replacement therapy.
(iii) To assess the types of dialysis utilisation over a 5 year time period among the total cohort of patients.
(iv)To determine how renal palliative care services were engaged for conservative care patients, and document the patient's place of death (i.e. hospital, hospice, home with community palliative care).
- Conditions
- Chronic Kidney Disease
- Being tested
- dialysis, kidney transplant
- Keywords
- chronic kidney disease, dialysis, pre dialysis education, transplantation, conservative care
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dialysis, kidney transplantProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Stage 5 chronic kidney disease | Patients receiving home hemodialysis Patients receiving home peritoneal dialysis Patients receiving center-based hemodialysis Patients who had a pre-emptive kidney transplant Patients who planned for renal conservative care Receives: Procedure: dialysis, kidney transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis.
Measured: 5 years
Secondary outcomes (1)
The proportion of patients who commence dialysis, or have a time-limited trial of dialysis within 3 and 5 years, after a confirmed plan for conservative care.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionSep 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Sydney South West Area Health Service, South West Sydney Local Health District, Kidney Health Australia
- Responsible party
- Sponsor
- Investigators
- Rachael L Morton, PhD, Principal investigator, University of Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768624
- Sponsor's protocol ID
- RM-1/12
- Status last verified
- Oct 2016
- First submitted
- 11 Jan 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Morton RL, Howard K, Webster AC, Snelling P. Patient INformation about Options for Treatment (PINOT): a prospective national study of information given to incident CKD Stage 5 patients. Nephrol Dial Transplant. 2011 Apr;26(4):1266-74. doi: 10.1093/ndt/gfq555. Epub 2010 Sep 6.
PubMed 20819955Morton RL, Turner RM, Howard K, Snelling P, Webster AC. Patients who plan for conservative care rather than dialysis: a national observational study in Australia. Am J Kidney Dis. 2012 Mar;59(3):419-27. doi: 10.1053/j.ajkd.2011.08.024. Epub 2011 Oct 20.
PubMed 22014401Morton RL, Webster AC, McGeechan K, Howard K, Murtagh FEM, Gray NA, Kerr PG, Germain MJ, Snelling P. Conservative Management and End-of-Life Care in an Australian Cohort with ESRD. Clin J Am Soc Nephrol. 2016 Dec 7;11(12):2195-2203. doi: 10.2215/CJN.11861115. Epub 2016 Oct 3.
PubMed 27697783
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.
- ClinicalTrials.gov ID
- NCT01768624
- Acronym / sponsor ID
- RM-1/12
- Conditions
- Chronic Kidney Disease
- Keywords
- chronic kidney disease, dialysis, pre dialysis education, transplantation, conservative care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 721 participants (actual)
- Lead sponsor
- University of SydneyUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Sydney South West Area Health Service, South West Sydney Local Health District, Kidney Health Australia
- Study start
- Oct 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Jan 2013 (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 primary aims of the Patient INformation about Options for Treatment (PINOT) Follow-up Study are to determine the proportions of patients, identified in the 2009 PINOT cohort that:
(i)Made the transition to home dialysis, after an initial start on center-based dialysis.
(ii)Commenced dialysis, or a time-limited trial of dialysis within 3 years, after confirmed plans for conservative care.
The hypotheses to be tested in the PINOT follow-up study are:
- 50% of stage 5 chronic kidney disease patients who plan for home dialysis do not commence home dialysis within 3 years, and instead remain on centre-based haemodialysis; and,
- less than 15% of stage 5 chronic kidney disease patients who plan for conservative care commence dialysis within 3 years.
Detailed description
The secondary aims of the follow-up study include:
(i) To assess the primary reasons patients did not transition to home dialysis, in the planned home dialysis group.
(ii)To compare 3 and 5 year survival rates among patients who commenced conservative care and patients who commenced renal replacement therapy.
(iii) To assess the types of dialysis utilisation over a 5 year time period among the total cohort of patients.
(iv)To determine how renal palliative care services were engaged for conservative care patients, and document the patient's place of death (i.e. hospital, hospice, home with community palliative care).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage 5 chronic kidney disease | – | Procedure: dialysis, kidney transplantPatients receiving home hemodialysis Patients receiving home peritoneal dialysis Patients receiving center-based hemodialysis Patients who had a pre-emptive kidney transplant Patients who planned for renal conservative care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices
Key inclusion criteria (1 listed)
- Adults and children with end stage kidney disease (eGFR <15 ml/min) who commenced renal replacement therapy or conservative care in Australia between July and September 2009
Key exclusion criteria (2 listed)
- Patients returning to dialysis after a failed transplant,
- Patients with acute renal failure
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 |
|---|---|---|
| dialysis, kidney transplant | Procedure or surgery | Stage 5 chronic kidney disease |
Primary outcome
The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis.
Time frame: 5 years
1 secondary outcome
The proportion of patients who commence dialysis, or have a time-limited trial of dialysis within 3 and 5 years, after a confirmed plan for conservative care.
Time frame: 5 years
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 26 Oct 2016.
- Background: PubMed 20819955Morton RL, Howard K, Webster AC, Snelling P. Patient INformation about Options for Treatment (PINOT): a prospective national study of information given to incident CKD Stage 5 patients. Nephrol Dial Transplant. 2011 Apr;26(4):1266-74. doi: 10.1093/ndt/gfq555. Epub 2010 Sep 6.
- Background: PubMed 22014401Morton RL, Turner RM, Howard K, Snelling P, Webster AC. Patients who plan for conservative care rather than dialysis: a national observational study in Australia. Am J Kidney Dis. 2012 Mar;59(3):419-27. doi: 10.1053/j.ajkd.2011.08.024. Epub 2011 Oct 20.
- Results publication: PubMed 27697783Morton RL, Webster AC, McGeechan K, Howard K, Murtagh FEM, Gray NA, Kerr PG, Germain MJ, Snelling P. Conservative Management and End-of-Life Care in an Australian Cohort with ESRD. Clin J Am Soc Nephrol. 2016 Dec 7;11(12):2195-2203. doi: 10.2215/CJN.11861115. Epub 2016 Oct 3.
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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.
Rachael L Morton, PhD principal investigator
University of Sydney
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by University of Sydney at 2 sites in 2 countries.
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 1 inclusion and 2 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01768624, which also lists 3 linked publications.
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 26 Oct 2016.