Twice-Weekly Hemodialysis for hemodialysis-dependent chronic kidney disease (HDD-CKD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
VA Long Beach Healthcare System, Long Beach, CA, Long Beach, CA
hemodialysis-dependent chronic kidney disease (HDD-CKD)+4 More
Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

In this pragmatic clinical trial, which will dovetail with Veterans' routine outpatient dialysis clinic visits in six VA medical centers, the investigators will study 252 Veterans with kidney disease who need to start dialysis treatment. If a Veteran is eligible for the study by making enough residual urine, he/she will have a 50% chance to be offered the usual three-times-per-week dialysis vs. twice-per-week dialysis that is gradually increased to three-times per- week over one year. The investigators will compare health-related quality of life, how long residual kidney function lasts, and other measures including safety in these two groups. By conducting this study, the investigators hope to understand 1) whether starting dialysis with less frequency is safe, effective, and can help Veterans and their care-partners to better cope with dialysis, and 2) if incremental dialysis can result in major cost benefits to the VA health care system, thus allowing more patients to stay in VA dialysis clinics vs. being transferred to outside clinics.

Eligible Conditions

  • hemodialysis-dependent chronic kidney disease (HDD-CKD)
  • Kidney Dysfunction Requiring Dialysis (KDRD)
  • Dialysis Dependency

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for hemodialysis-dependent chronic kidney disease (HDD-CKD)

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Change over 12 months based on measuring at baseline and at Month 6, and 12 in the sub-study of 112 participants

Month 12
Change over time in Serum level of Growth Differentiation Factor 15 (GDF15)
Change over time in in numeric score of Dialysis Symptom Index (DSI)
Change over time in numeric scale of Health-Related Quality of Life (HRQOL) Physical Component Score (PCS) of SF36 questionnaire.
Change over time in numeric scale of Malnutrition-Inflammation Score (MIS)
Change over time in numeric scale of SF36 Energy/Fatigue Subscale off SF36 HRQOL
Change over time in numeric value of Total Dialysis Adequacy (KT/V, sum of dialysis and residual kidney urea clearance)
Change over time in residual urine output (UOP) in ml/day
Month 12
Change over time in mid-arm muscle circumference (MAMC) in cm
Change over time in numeric scale of Short Physical Performance Battery (SPPB)
Month 12
Change over time in Left Ventricular (LV) mass

Trial Safety

Safety Progress

1 of 3

Other trials for hemodialysis-dependent chronic kidney disease (HDD-CKD)

Trial Design

2 Treatment Groups

Twice-Weekly Hemodialysis
1 of 2
Thrice-Weekly Hemodialysis
1 of 2
Experimental Treatment
Non-Treatment Group

252 Total Participants · 2 Treatment Groups

Primary Treatment: Twice-Weekly Hemodialysis · Has Placebo Group · N/A

Twice-Weekly Hemodialysis
Other
Experimental Group · 1 Intervention: Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule · Intervention Types: Other
Thrice-Weekly Hemodialysis
Other
PlaceboComparator Group · 1 Intervention: Thrice-Weekly Hemodialysis · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change over 12 months based on measuring at baseline and at month 6, and 12 in the sub-study of 112 participants
Closest Location: VA Long Beach Healthcare System, Long Beach, CA · Long Beach, CA
2011First Recorded Clinical Trial
1 TrialsResearching hemodialysis-dependent chronic kidney disease (HDD-CKD)
13 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are eligible for the IncHVets Study.
You are willing to undergo the randomly assigned modality of 2x/wk vs 3x/wk HD.
You are willing to attend the baseline and quarterly study tests in the dialysis unit or via telehealth as determined by study staff, which will mostly be parallel to the routine dialysis clinic visits.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.