Incremental vs Conventional Hemodialysis for Kidney Failure

Recruiting in Palo Alto (17 mi)

+15 other locations

Overseen by David Johnson, Prof

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Queensland

Disqualifiers: Low urine output, others

No Placebo Group

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.

^{1 2 3 4 5}

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.

^{2 4 6 7 8}

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.

^{1 3 4 5 9}

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.

I am 18 years old or older.

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.

Trial 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

Participant Groups

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.

Group I: Incremental HD Experimental Treatment 1 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 HD Experimental Treatment 1 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

Research Locations Nearby Select from list below to view details:

Who Is Running the Clinical Trial?

The University of Queensland Lead Sponsor

Medical Research Future Fund Collaborator

Queensland Health Collaborator

Canadian Institutes of Health Research (CIHR) Collaborator

References

1. Italy pubmed.ncbi.nlm.nih.gov

Could incremental haemodialysis be a new standard of care? A suggestion from a long-term observational study. [2022] Introduction: The term incremental haemodialysis (HD) means that both dialysis dose and frequency can be low at dialysis inception but should be progressively increased, to compensate for any subsequent reduction in residual kidney function. Policy of the Matera Dialysis Center is to attempt an incremental start of HD without a strict low-protein diet in all patients choosing HD and with urine output (UO) >500 ml/day. The present study aimed at analyzing the results of this policy over the last 20 years. Subjects and methods: The dataset of all patients starting HD between January 1st, 2000 and December 31st, 2019 was retrieved from the local electronic database. Exclusion criteria were: urine output <500 ml/day or follow-up <3 months after the start of the dialysis treatment. Results: A total of 266 patients were retrieved; 64 of them were excluded from the study. The remaining 202 patients were enrolled into the study and subdivided into 3 groups (G1, G2 and G3) according to the frequency of treatment at the start of dialysis: 117 patients (57.9%) started with once-a-week (1HD/wk) (G1); 46 (22.8%) with twice-a-week (2HD/wk) (G2); 39 (19.3%) with thrice-a-week (3HD/wk) dialysis regimen (G3). Patients of G1 remained on 1HD/wk for 11.9 ±14.8 months and then transferred to 2HD/wk for further 13.0 ±20.3 months. Patients of G2 remained on 2HD/wk for 16.7 ±23.2 months. Altogether, 25943 sessions were administered during the less frequent treatment periods instead of 47988, that would have been delivered if the patients had been on 3HD/wk, thus saving 22045 sessions (45.9%). Gross mortality of the entire group was 12.6%, comparable to the mean mortality of the Italian dialysis population (16.2%). Survival at 1 and 5 years was not significantly different among the 3 groups: 94% and 61% (G1); 83% and 39% (G2); 84% and 46% (G3). Conclusions: Our long-term observational study suggests that incremental HD is a valuable option for incident patients. For most of them (80.7%) it is viable for about 1-2 years, with obvious socio-economic benefits and survival rates comparable to that of the Italian dialysis population. However, randomized controlled trials are lacking and therefore urgently needed. If they will confirm observational data, incremental HD will be a new standard of care.

2. United States pubmed.ncbi.nlm.nih.gov

Treatment frequency and mortality among incident hemodialysis patients in the United States comparing incremental with standard and more frequent dialysis. [2022] Most patients with end-stage renal disease in the United States are initiated on thrice-weekly hemodialysis (HD) regimens. However, an incremental approach to HD may provide several patient benefits. We tested whether initiation of incremental HD does or does not compromise survival compared with a conventional HD regimen. The survival of 434 incremental, 50,162 conventional, and 160 frequent HD patients were compared using Cox regression analysis after matching for demographic and comorbid factors in a longitudinal national cohort of adult incident HD patients enrolled between January 2007 and December 2011. Sensitivity analysis included adjustment for residual kidney function. After adjustment for residual kidney function, all-cause mortality was not significantly different in the incremental compared with conventional HD group (hazard ratio 0.88, 95% confidence interval 0.72-1.08), but was higher in the frequent compared with the conventional HD group (hazard ratio, 1.56, 95% confidence interval 1.21-2.03). The comorbidity burden modified the association of treatment frequency and mortality, with higher comorbidity associated with higher mortality in the incremental HD group (hazard ratio, 1.77, 95% confidence interval 1.20-2.62) for a Charlson Comorbidity Index of ≥5. Thus, among incident HD patients with low or moderate comorbid disease, survival was similar for patients initiated on an incremental or conventional HD regimen. Clinical trials are needed to examine the safety and effectiveness of incremental HD and the selected patient populations who may benefit from an incremental approach to HDs initiation.

3. England pubmed.ncbi.nlm.nih.gov

Knowledge and Practice of Incremental Hemodialysis: A Survey of Canadian Nephrologists. [2023] Incremental hemodialysis, a strategy to individualize dialysis prescription based on residual kidney function, may be associated with enhanced quality of life and decreased health care costs compared with conventional hemodialysis.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Hemodynamic and Laboratory Changes during Incremental Transition from Twice to Thrice-Weekly Hemodialysis. [2021] Incremental hemodialysis (HD) is a strategy utilized to gradually intensify dialysis among patients with incident end-stage renal disease. However, there are scarce data about which patients' clinic status changes by increasing treatment frequency.

5. Canada pubmed.ncbi.nlm.nih.gov

Comparison of characteristics of centers practicing incremental vs. conventional approaches to hemodialysis delivery - postdialysis recovery time and patient survival. [2020] Conventional haemodialysis (HD) involves treatment times of around 4 hours thrice weekly, taking no account of residual kidney function (RKF). In incremental HD the frequency and duration of dialysis sessions are individualized according to RKF. There are no studies comparing these approaches. We utilized data from a recent multicenter study to compare patient characteristics and outcomes between a center practicing incremental HD and others using a conventional approach.

6. Italy pubmed.ncbi.nlm.nih.gov

Incremental dialysis in ESRD: systematic review and meta-analysis. [2020] Incremental dialysis may preserve residual renal function and improve survival in comparison with full-dose dialysis; however, available evidence is limited. We therefore compared all-cause mortality and residual kidney function (RKF) loss in incremental and full-dose dialysis and time to full-dose dialysis in incremental hemodialysis (IHD) and incremental peritoneal dialysis (IPD).

7. Japan pubmed.ncbi.nlm.nih.gov

A mixed-method feasibility study of a novel transitional regime of incremental haemodialysis: study design and protocol. [2022] Incremental haemodialysis/haemodiafiltration (HD) may help reduce early mortality rates in patients starting HD. This mixed-method feasibility study aims to test the acceptability, tolerance and safety of a novel incremental HD regime, and to study its impact on parameters of patient wellbeing.

8. United States pubmed.ncbi.nlm.nih.gov

Australian Workshops on Patients' Perspectives on Hemodialysis and Incremental Start. [2023] Most patients with kidney failure commence and continue hemodialysis (HD) thrice weekly. Incremental initiation (defined as HD less than thrice weekly) is increasingly considered to be safe and less burdensome, but little is known about patients' perspectives. We aimed to describe patients' priorities and concerns regarding incremental HD.

9. England pubmed.ncbi.nlm.nih.gov

Incremental short daily home hemodialysis: a case series. [2018] Patients starting dialysis often have substantial residual kidney function. Incremental hemodialysis provides a hemodialysis prescription that supplements patients' residual kidney function while maintaining total (residual + dialysis) urea clearance (standard Kt/Vurea) targets. We describe our experience with incremental hemodialysis in patients using NxStage System One for home hemodialysis.