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Incremental vs Conventional Hemodialysis for Kidney Failure
N/A
Recruiting
Led By Andrea Viecelli, Dr
Research Sponsored by The University of Queensland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Commencing HD as their initial dialysis therapy
Adults (≥ 18 years of age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3, 6, 9, 12, 15 and 18 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if dialysis is a safe, practical, and cost-effective way to improve quality of life for dialysis patients and families.
Who is the study for?
The INCH-HD trial is for adults over 18 who are starting hemodialysis (HD) as their first treatment for kidney failure. They must be able to consent to the study and likely stay on HD for at least a year. People with urine output less than half a liter per day can't join.
What is being tested?
This trial compares incremental HD, which gradually increases dialysis frequency, with conventional HD that uses a regular schedule from the start. It aims to see if incremental HD better maintains quality of life and is safe and cost-effective.
What are the potential side effects?
While specific side effects aren't listed here, typical risks associated with hemodialysis may include low blood pressure, muscle cramps, itching, sleep problems, anemia, bone diseases, high blood potassium levels or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am starting hemodialysis as my first dialysis treatment.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3, 6, 9, 12, 15 and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3, 6, 9, 12, 15 and 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Heath related quality of life
Secondary study objectives
Adverse events and side-effects
Fatigue
Healthcare costs
+13 moreOther study objectives
Patient lifestyle and wellbeing
Time to event
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Incremental HDExperimental Treatment1 Intervention
Participants randomised to incremental HD will commence HD twice weekly and continue until an indication for an increase to three sessions/week (trigger point) is reached.
Group II: Conventional HDExperimental Treatment1 Intervention
Participants randomised to conventional HD will commence HD thrice weekly from the first HD session.
Find a Location
Who is running the clinical trial?
The University of QueenslandLead Sponsor
145 Previous Clinical Trials
69,912 Total Patients Enrolled
Medical Research Future FundOTHER
9 Previous Clinical Trials
209,786 Total Patients Enrolled
Queensland HealthOTHER_GOV
4 Previous Clinical Trials
1,716 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,393 Previous Clinical Trials
26,527,292 Total Patients Enrolled
Andrea Viecelli, DrPrincipal InvestigatorUniversity of Queensland, Queensland Health
Charmaine Lok, ProfPrincipal InvestigatorUniversity Health Network, Toronto
David Johnson, ProfPrincipal InvestigatorUniversity of Queensland, Queensland Health
Peter Kerr, ProfPrincipal InvestigatorUniversity of Queensland, Monash University
Martin Wolley, DrPrincipal InvestigatorUniversity of Queensland, Queensland Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am starting hemodialysis as my first dialysis treatment.I am 18 years old or older.Unlikely to have been on hemodialysis for at least 1 year.You are not producing enough urine each day.
Research Study Groups:
This trial has the following groups:- Group 1: Incremental HD
- Group 2: Conventional HD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.