PINOT Follow-up Study in End-stage Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01768624
• Other study ID #: RM-1/12
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: October 24, 2016
• Start date: October 2012
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University of Sydney
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical 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.

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 721
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients returning to dialysis after a failed transplant,

• Patients with acute renal failure

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Procedure:
• dialysis, kidney transplant

Locations

Country	Name	City	State
Australia	University of Sydney	Sydney	New South Wales
United Kingdom	University of Oxford	Headington	Oxfordshire

Sponsors (5)

Lead Sponsor	Collaborator
University of Sydney	Kidney Health Australia, National Health and Medical Research Council, Australia, South West Sydney Local Health District, Sydney South West Area Health Service

Countries where clinical trial is conducted

Australia,  United Kingdom, 

References & 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. — View Citation

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. — View Citation

Morton RL, Webster AC, McGeechan K, Howard K, Murtagh FE, 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 Oct 3. pii: CJN.11861115. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis.		5 years	No
Secondary	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	No

External Links

•   Principal investigator profile