Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)

NCT05465044 | Recruiting DMC

• 2 other identifiers: NEPH-003-21FCX002382
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Chronic Kidney Disease (CKD) Stage 5; Kidney Dysfunction Requiring Dialysis (KDRD); Dialysis Dependency

Keywords

chronic kidney disease (CKD); Residual kidney function (RKF); Uremia; End-stage Renal Disease (ESRD); Hemodialysis; Dialysis adequacy

Outcome Measures

Primary Outcomes (1)

• Change over time in numeric scale of Health-Related Quality of Life (HRQOL) Physical Component Score (PCS) of SF36 questionnaire.

  The primary endpoint under Aim 1 will be HRQOL Physical Component Score (PCS) measured by the SF36, assessed at baseline and Month 3, 6, 9 and 12. SF36 questionnaires will be administered by trained assessors blinded to the intervention assignment using computer adapted telephone interviewing for SF36. It is a numeric value from 0 (worse) to 100 (best HRQOL physical score).

  Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12

Secondary Outcomes (6)

• Change over time in numeric scale of SF36 Energy/Fatigue Subscale off SF36 HRQOL

  Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12

• Change over time in in numeric score of Dialysis Symptom Index (DSI)

  Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12

• Change over time in residual urine output (UOP) in ml/day

  Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12

• Change over time in numeric value of Total Dialysis Adequacy (KT/V, sum of dialysis and residual kidney urea clearance)

  Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12

• Change over time in numeric scale of Malnutrition-Inflammation Score (MIS)

  Change over 12 months based on measuring at baseline and at Month 3, 6, 9 and 12

Other Outcomes (3)

• Change over time in numeric scale of Short Physical Performance Battery (SPPB)

  Change over 12 months based on measuring at baseline and at Month 6, and 12 in the sub-study of 112 participants

• Change over time in mid-arm muscle circumference (MAMC) in cm

  Change over 12 months based on measuring at baseline and at Month 6, and 12 in the sub-study of 112 participants

• Change over time in Left Ventricular (LV) mass

  Over 12 months (from baseline and at Month 12) in the sub-study of 112 participants

Study Arms (2)

Twice-Weekly Hemodialysis

EXPERIMENTAL

Twice-weekly hemodialysis with incremental crossover to thrice-weekly hemodialysis as indicated

Other: Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule

Thrice-Weekly Hemodialysis

PLACEBO COMPARATOR

Outright thrice-weekly hemodialysis without option to switch to less frequent dialysis schedule

Other: Thrice-Weekly Hemodialysis

Interventions

Twice-weekly hemodialysis with incremental crossover to thrice-weekly schedule OTHER

50% of the eligible participants will be assigned to twice-weekly hemodialysis for up to 12 months with incremental crossover to thrice-weekly hemodialysis as indicated.

Twice-Weekly Hemodialysis

Thrice-Weekly Hemodialysis OTHER

50% of the eligible participants will be assigned to outright thrice-weekly hemodialysis, which will be continuation of the initial thrice-weekly schedule during the run-in period, without the option to switch to less frequent dialysis schedule representing the standard of care.

Thrice-Weekly Hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Veterans diagnosed with ESRD and who will soon need chronic dialysis initiation or have initiated hemodialysis (HD) not longer than 8 weeks of the target randomization day in one of the six VA centers.
• Meeting the incremental dialysis eligibility criteria in Table 4\* under the IncHVets Study Protocol.
• Willingness to undergo the randomly assigned modality of 2x/wk vs 3x/wk HD.
• Willingness 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.
• Agreeable to receive monthly or more frequent reviews for and interviews, regardless of being assigned to the incremental or conventional dialysis group.
• As shown in Table 4 of the INCHVETS Study protocol under incremental dialysis criteria, eligible subjects must have a urine output \>0.5 L/day and urea clearance (KRU) \>3 ml/min and meet 5 or more of the 9 other incremental dialysis criteria , which are derived from the 2014 Incremental Dialysis Consensus paper (Kalantar-Zadeh et al. Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy. Am J Kidney Dis. 2014 Aug;64(2):181-6. doi: 10.1053/j.ajkd.2014.04.019. PMID: 24840669 PMCID: PMC4111970)

You may not qualify if:

• Having a terminal illness with a life expectancy less than 6 months such as stage 4 metastatic cancer or having signed for hospice with life expectancy less than 6 months.
• A serum potassium level \>6.0 mEq/L during the 4 weeks prior to the study start.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (6)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

RECRUITING

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

RECRUITING

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

RECRUITING

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153, United States

RECRUITING

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011, United States

RECRUITING

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104-2127, United States

RECRUITING

Related Links

• INCHVETS study updates and announcements will be posted here

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Uremia; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kamyar Kalantar-Zadeh, MD PhD

  VA Long Beach Healthcare System, Long Beach, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamyar Kalantar-Zadeh, MD PhD

CONTACT

(562) 826-8000; Kamyar.Kalantar-Zadeh@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors blinded to the study intervention will interview patients using computer-adapted telephone interviewing for the main outcome measure (SF36 PCS)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Pragmatic randomized controlled trial (RCT)

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 19, 2022
• Study Start: April 1, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)