372 Participants Needed

Incremental vs Conventional Hemodialysis for Kidney Failure

Recruiting at 15 trial locations
AS
RS
Overseen ByRuth Stastny
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Queensland
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The INCH-HD trial will test if incremental HD preserves the quality of life of patients and families and is a safe, practical, cost effective treatment option.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Incremental Hemodialysis for Kidney Failure?

Incremental hemodialysis, which adjusts treatment based on remaining kidney function, may improve quality of life and reduce healthcare costs compared to conventional hemodialysis. Studies suggest that survival rates for patients using incremental hemodialysis are similar to those using conventional methods, with potential socio-economic benefits.12345

Is incremental hemodialysis safe for patients with kidney failure?

Incremental hemodialysis is considered safe and may offer benefits like preserving kidney function and improving survival compared to full-dose dialysis. Studies show that survival rates are similar between incremental and conventional hemodialysis, especially for patients with low or moderate additional health issues.24678

How does incremental hemodialysis differ from conventional hemodialysis for kidney failure?

Incremental hemodialysis is unique because it tailors the frequency and duration of dialysis sessions based on a patient's remaining kidney function, starting with fewer sessions and increasing as needed, which can enhance quality of life and reduce healthcare costs compared to the standard thrice-weekly schedule of conventional hemodialysis.13459

Research Team

DJ

David Johnson, Prof

Principal Investigator

University of Queensland, Queensland Health

PK

Peter Kerr, Prof

Principal Investigator

University of Queensland, Monash University

AV

Andrea Viecelli, Dr

Principal Investigator

University of Queensland, Queensland Health

CL

Charmaine Lok, Prof

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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.

Inclusion Criteria

I am starting hemodialysis as my first dialysis treatment.
Able to give informed consent

Exclusion Criteria

Unlikely to have been on hemodialysis for at least 1 year.
You are not producing enough urine each day.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either incremental HD (twice weekly) or conventional HD (thrice weekly) based on randomization

6 months
Regular HD sessions as per assigned group

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Monthly assessments

Extension

Continued monitoring and assessment of health-related quality of life and other outcomes

6 months

Treatment Details

Interventions

  • Conventional HD
  • Incremental HD
Trial Overview 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.
Participant Groups
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.

Conventional HD is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺
Approved in European Union as Hemodialysis for:
  • Acute kidney injury
  • Chronic kidney disease
  • End-stage renal disease
  • Uremic encephalopathy
  • Pericarditis
  • Life-threatening hyperkalemia
  • Refractory acidosis
  • Hypervolemia causing end-organ complications
🇺🇸
Approved in United States as Hemodialysis for:
  • Acute kidney injury
  • Chronic kidney disease
  • End-stage renal disease
  • Uremic encephalopathy
  • Pericarditis
  • Life-threatening hyperkalemia
  • Refractory acidosis
  • Hypervolemia causing end-organ complications
🇨🇦
Approved in Canada as Hemodialysis for:
  • Acute kidney injury
  • Chronic kidney disease
  • End-stage renal disease
  • Uremic encephalopathy
  • Pericarditis
  • Life-threatening hyperkalemia
  • Refractory acidosis
  • Hypervolemia causing end-organ complications
🇯🇵
Approved in Japan as Hemodialysis for:
  • Acute kidney injury
  • Chronic kidney disease
  • End-stage renal disease
  • Uremic encephalopathy
  • Pericarditis
  • Life-threatening hyperkalemia
  • Refractory acidosis
  • Hypervolemia causing end-organ complications
🇨🇳
Approved in China as Hemodialysis for:
  • Acute kidney injury
  • Chronic kidney disease
  • End-stage renal disease
  • Uremic encephalopathy
  • Pericarditis
  • Life-threatening hyperkalemia
  • Refractory acidosis
  • Hypervolemia causing end-organ complications
🇨🇭
Approved in Switzerland as Hemodialysis for:
  • Acute kidney injury
  • Chronic kidney disease
  • End-stage renal disease
  • Uremic encephalopathy
  • Pericarditis
  • Life-threatening hyperkalemia
  • Refractory acidosis
  • Hypervolemia causing end-organ complications

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Queensland

Lead Sponsor

Trials
149
Recruited
71,700+

Medical Research Future Fund

Collaborator

Trials
10
Recruited
210,000+

Queensland Health

Collaborator

Trials
5
Recruited
2,100+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Findings from Research

Incremental hemodialysis (HD) allows patients to start with lower frequency treatments, which can be gradually increased, and this approach was shown to be viable for about 1-2 years for 80.7% of patients, leading to significant savings in treatment sessions (45.9%).
The survival rates of patients on incremental HD were comparable to the overall Italian dialysis population, with a gross mortality rate of 12.6%, suggesting that this method is a safe and effective option for new dialysis patients.
Could incremental haemodialysis be a new standard of care? A suggestion from a long-term observational study.Casino, FG., Lopez, T., Santarsia, G., et al.[2022]
In a study of 434 patients on incremental hemodialysis (HD) compared to 50,162 on conventional HD, survival rates were similar, suggesting that starting with an incremental approach does not compromise patient survival for those with low to moderate comorbidities.
However, patients with higher comorbidity (Charlson Comorbidity Index ≥5) showed increased mortality in the incremental HD group, indicating that patient selection is crucial and further clinical trials are needed to assess the safety and effectiveness of this approach.
Treatment frequency and mortality among incident hemodialysis patients in the United States comparing incremental with standard and more frequent dialysis.Mathew, A., Obi, Y., Rhee, CM., et al.[2022]
A survey of 243 Canadian nephrologists revealed that 65% prescribe incremental hemodialysis based on individual patient needs, indicating a trend towards personalized treatment in kidney care.
Despite a general agreement on the importance of considering residual kidney function in dialysis prescriptions, 74% of nephrologists felt there was insufficient evidence supporting the effectiveness of incremental hemodialysis, highlighting a need for more research to address safety and implementation challenges.
Knowledge and Practice of Incremental Hemodialysis: A Survey of Canadian Nephrologists.Dahiya, A., Bello, A., Thompson, S., et al.[2023]

References

Could incremental haemodialysis be a new standard of care? A suggestion from a long-term observational study. [2022]
Treatment frequency and mortality among incident hemodialysis patients in the United States comparing incremental with standard and more frequent dialysis. [2022]
Knowledge and Practice of Incremental Hemodialysis: A Survey of Canadian Nephrologists. [2023]
Hemodynamic and Laboratory Changes during Incremental Transition from Twice to Thrice-Weekly Hemodialysis. [2021]
Comparison of characteristics of centers practicing incremental vs. conventional approaches to hemodialysis delivery - postdialysis recovery time and patient survival. [2020]
Incremental dialysis in ESRD: systematic review and meta-analysis. [2020]
A mixed-method feasibility study of a novel transitional regime of incremental haemodialysis: study design and protocol. [2022]
Australian Workshops on Patients' Perspectives on Hemodialysis and Incremental Start. [2023]
Incremental short daily home hemodialysis: a case series. [2018]