Dialysis and Supportive Care in Elderly patients with advanced Renal disease

Not Applicable

• Conditions: End Stage Kidney disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12617001532392
• Lead Sponsor: The George Institute for Global Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-06
• Last Update Posted: 30 September 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Aged greater than or equal to 75 years
2.With advanced chronic kidney disease, defined as having an eGFR of less than or equal to 12 ml/min/1.73m2
3.Is expected by their treating physician to meet clinical criteria for entry to a maintenance dialysis program within the next 24 months.
4.Has satisfied the treating unit’s policies relating to education regarding end stage kidney disease treatment options
5.The treating physician caring for the participant has equipoise about the balance of risk and benefit for the participant should they enter either treatment arm of the study.

Exclusion Criteria

1.Treating physician considers it unlikely that the participant will adhere to allocated study treatment
2.Participant unable to understand the implications of both of the study treatment arms for their future care
3. The treating physician expects that the participant will not survive 3 months beyond study randomisation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality[Within 3 years of randomisation<br>]

Secondary Outcome Measures

Name	Time	Method
Extent of deviation from allocated study treatment arm[Over 3 year follow period];Quality of life, as measured by EQ-5D-3L Health Questionnaire and Satisfaction with Life scale[6 months, 12 months, 24 months, 36 months];Health resource utilisation through total hospital bed days, total cost weights of hospital care and total medical procedures (insertion of dialysis access, interventional radiology procedures, surgical procedures)[within 3 years of study follow up period];Symptom burden of participants, as measured by iPOS-Renal scale questionnaire completed by participants[Baseline, 6 months, 12 months, 24 months, 36 months];Functional Status as assessed by Renal Physician [Baseline, 6 months, 12 months, 24 months, 36 months]