Incremental Hemodialysis Frequency for Kidney Failure
Recruiting in Palo Alto (17 mi)
+11 other locations
Overseen byMariana Murea, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Pregnancy, High potassium, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function.
The study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. Patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. Caregivers will be followed along with patients for an average period of 2 years post randomization.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of incremental hemodialysis for kidney failure?
Research suggests that incremental hemodialysis, which starts with fewer sessions per week, may help preserve remaining kidney function and improve patient comfort compared to the standard thrice-weekly schedule. This approach is particularly beneficial for patients who still have some kidney function left when they begin dialysis.
12345Is incremental hemodialysis safe for humans?
Incremental hemodialysis, which involves starting with fewer sessions per week and increasing as needed, is considered safe and less burdensome for patients with kidney failure. Studies suggest it may help preserve remaining kidney function and improve quality of life.
12367What makes Incremental Hemodialysis unique compared to other treatments for kidney failure?
Incremental Hemodialysis is unique because it starts with less frequent sessions, such as once or twice a week, which can be easier on patients and help preserve remaining kidney function longer. This approach is more personalized and can be adjusted based on the patient's needs, unlike the standard thrice-weekly schedule.
12368Eligibility Criteria
Adults over 18 with new-onset kidney dysfunction requiring dialysis can join this trial. They should have started or be starting in-center hemodialysis soon, and not been on it for more than 6 weeks. Participants need some remaining kidney function and urine output. Those with certain blood chemistry imbalances, high fluid removal needs, a short life expectancy, or pregnancy are excluded.Inclusion Criteria
I am 18 years old or older.
I am on or will start dialysis soon due to kidney problems.
I have had 18 or fewer dialysis sessions over 6 weeks or less.
+2 more
Exclusion Criteria
You need or may need a lot of fluid removed from your blood.
Your blood test shows high potassium, low sodium, or low bicarbonate levels before the study.
I am unable to follow or unwilling to commit to the study's requirements.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to either incremental hemodialysis or conventional hemodialysis
2 years
Regular visits as per hemodialysis schedule
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Caregiver Follow-up
Caregivers are followed along with patients to assess caregiver burden and quality of life
2 years
Participant Groups
The TwoPlus Trial is comparing two schedules of hemodialysis for people with kidney failure: one group will receive treatments twice a week while the other will have them three times a week. The goal is to see which frequency is better when patients still have some kidney function left.
2Treatment groups
Experimental Treatment
Active Control
Group I: Clinically-matched Incremental Hemodialysis ( CMIHD)Experimental Treatment1 Intervention
Randomized group to have hemodialysis prescription tailored based on residual kidney function and clinical manifestations starting at twice weekly.
Group II: Conventional Hemodialysis (CHD)Active Control1 Intervention
Randomized group to conventional three times a week hemodialysis.
Conventional Hemodialysis is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Conventional Hemodialysis for:
- End-stage kidney disease
- Chronic kidney disease progressing to dialysis-dependent kidney disease
🇪🇺 Approved in European Union as Conventional Hemodialysis for:
- End-stage kidney disease
- Chronic kidney disease progressing to dialysis-dependent kidney disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Harbor University of California Los AngelesTorrance, CA
Indiana University (IU)Indianapolis, IN
Emory UniversityAtlanta, GA
University of North Carolina Chapel HillChapel Hill, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
Patient-Centered Outcomes Research InstituteCollaborator
References
Is more frequent hemodialysis beneficial and what is the evidence? [2019]The HEMO study results have shown that increasing dialysis dose in conventional thrice weekly hemodialysis does not improve patient outcomes. Interest has therefore turned to more frequent (daily) hemodialysis treatments. This review covers the rationale for such an approach together with a current review of the published study data.
Twice-Weekly Hemodialysis With Adjuvant Pharmacotherapy and Transition to Thrice-Weekly Hemodialysis: A Pilot Study. [2023]Thrice-weekly hemodialysis (HD) is the most common treatment modality for kidney failure in the United States. We conducted a pilot study to assess the feasibility and safety of incremental-start HD in patients beginning maintenance HD.
The ABCs of personalized incremental dialysis start, Le Mans style. [2023]Thrice weekly hemodialysis (HD) is considered the standard of care for patients with end-stage chronic kidney disease (CKD) on extracorporeal renal replacement therapy. However, recent evidence has shown that up to one third of patients start dialysis with a residual kidney function that could allow a reduced frequency/dialysis dose. Interest towards HD schedules other than thrice weekly and the lessons learned from peritoneal dialysis, in addition to growing attention to patients' quality of life, have promoted renewed attention towards incremental HD (iHD). iHD comprises once and twice weekly schedules, makes it possible to soften the "dialysis shock" at the inception of therapy and is patient-friendly. Moreover, it might contribute to preserving residual kidney function longer. Nevertheless, iHD is performed differently in different settings and no guidelines exist on this subject. Taking advantage of the experience accrued with regard to the treatment of advanced CKD both in the outpatient clinic and in the dialysis unit in Le Mans, where two thirds of incident HD patients start in an incremental way, we aimed to present the practical aspects of iHD and discuss its advantages and drawbacks.
More intensive hemodialysis. [2009]Clinical outcomes have not improved substantially for patients treated with conventional thrice weekly hemodialysis. More intensive hemodialysis regimens, including daily short dialysis, and nocturnal prolonged dialysis show promise to improve morbidity and mortality. Published studies and trials underway examining these therapies are reviewed.
What Is Known and Unknown About Twice-Weekly Hemodialysis. [2018]The 2006 Kidney Disease Outcomes Quality Initiative guidelines suggest twice-weekly or incremental hemodialysis for patients with substantial residual kidney function (RKF). However, in most affluent nations de novo and abrupt transition to thrice-weekly hemodialysis is routinely prescribed for all dialysis-naïve patients regardless of their RKF. We review historical developments in hemodialysis therapy initiation and revisit twice-weekly hemodialysis as an individualized, incremental treatment especially upon first transitioning to hemodialysis therapy.
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.
Impact of incremental initiation of haemodialysis on mortality: a systematic review and meta-analysis. [2023]Incremental haemodialysis initiation entails lower sessional duration and/or frequency than the standard 4 h thrice-weekly approach. Dialysis dose is increased as residual kidney function (RKF) declines. This systematic review evaluates its safety, efficacy and cost-effectiveness.
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.