NCT03874117

Brief Summary

The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

September 3, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

6.2 years

First QC Date

March 10, 2019

Results QC Date

July 7, 2025

Last Update Submit

August 13, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • QOL: Kidney Disease Quality of Life (KDQOL36)

    Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100.

    4 weeks

Secondary Outcomes (4)

  • Solute Concentration

    4 weeks

  • Symptom

    4 weeks

  • Trail B Making Test

    4 weeks

  • Digit Symbol Substitution Test

    4 weeks

Study Arms (2)

Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

OTHER

Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.

Other: Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

OTHER

Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Other: Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

Interventions

Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.

Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients on hemodialysis who have residual kidney function with residual urea clearance (Kru) \>2.5 mL/min.
  • been on hemodialysis for at least 3 months.
  • adherence to regular dialysis treatments.

You may not qualify if:

  • inability to achieve adequate hemodialysis.
  • planned revision of hemodialysis vascular access.
  • hospitalized within the past 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Satellite HealthCare

San Jose, California, 95128, United States

Location

Related Publications (1)

  • Lee S, Pham NM, Montez-Rath ME, Bolanos CG, Bonde SS, Meyer TW, Sirich TL. Twice Weekly versus Thrice Weekly Hemodialysis-A Pilot Cross-Over Equivalence Trial. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1159-1168. doi: 10.2215/CJN.0000000000000507. Epub 2024 Jun 26.

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Tammy Sirich
Organization
VA Palo Alto

Study Officials

  • Tammy Sirich, MD

    Stanford/VA Palo Alto Health Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2019

First Posted

March 14, 2019

Study Start

July 1, 2018

Primary Completion

September 1, 2024

Study Completion

May 31, 2025

Last Updated

September 3, 2025

Results First Posted

September 3, 2025

Record last verified: 2025-08

Locations