NCT01768624

Brief 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. (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:

  1. 1.50% 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,
  2. 2.less than 15% of stage 5 chronic kidney disease patients who plan for conservative care commence dialysis within 3 years.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
721

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.9 years

First QC Date

January 11, 2013

Last Update Submit

October 24, 2016

Conditions

Chronic Kidney Disease

Keywords

chronic kidney diseasedialysispre dialysis educationtransplantationconservative care

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis.

    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.

    5 years

Study Arms (1)

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

Procedure: dialysis, kidney transplant

Interventions

dialysis, kidney transplantPROCEDURE
Stage 5 chronic kidney disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults and children with chronic kidney disease attending renal treatment centres in Australian public hospitals and private practices

You may qualify if:

  • 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

You may not qualify if:

  • Patients returning to dialysis after a failed transplant,
  • Patients with acute renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Sydney

Sydney, New South Wales, 2006, Australia

Location

University of Oxford

Headington, Oxfordshire, OX38QY, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 20819955BACKGROUND

  • Morton 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.

    PMID: 22014401BACKGROUND

  • Morton 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.

    PMID: 27697783RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

DialysisKidney Transplantation

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemistry Techniques, AnalyticalInvestigative TechniquesChemical PhenomenaRenal Replacement TherapyTherapeuticsOrgan TransplantationTransplantationSurgical Procedures, OperativeUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Rachael L Morton, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 15, 2013

Study Start

October 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

AU(1)GB(1)