Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

August 13, 2025 updated by: Tammy Sirich, Palo Alto Veterans Institute for Research
The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hemodialysis patients who have residual kidney function will undergo two 4-week study (twice weekly versus thrice weekly hemodialysis) using a cross-over design. Blood, urine, and dialysate samples will be collected at the end of each study period to determine adequacy of treatment and to assess uremic solute levels. Participants will complete quality of life questionnaires and cognitive paper tests.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center
      • San Jose, California, United States, 95128
        • Satellite Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis
Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.
Other: Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis
Twice weekly hemodialysis for 4 weeks, then thrice weekly hemodialysis for 4 weeks.
Other: Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis
Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.
Other: Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis
Thrice weekly hemodialysis for 4 weeks, then twice weekly hemodialysis for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QOL: Kidney Disease Quality of Life (KDQOL36)
Time Frame: 4 weeks
Kidney Disease Quality of Life: Health-related quality of life, with higher scores being better. Minimum is 0, maximum is 100.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom
Time Frame: 4 weeks
Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
4 weeks
Solute Concentration
Time Frame: 4 weeks
Plasma concentration of p-cresol sulfate
4 weeks
Trail B Making Test
Time Frame: 4 weeks
Cognitive test: The Trail B Making Test assesses working memory, cognitive flexibility, processing speed, and visual-motor tracking. There are numbers and letters on a page. The participant must connect the number to letter in order. For example, they would start at 1 and draw a line to A, then draw a line to 2, then draw a line to B, then draw a line to 3. The time is recorded in seconds.
4 weeks
Digit Symbol Substitution Test
Time Frame: 4 weeks
Cognitive test: Digit Symbol Substitution Test, measured in number correct
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Tammy Sirich, MD, Stanford/VA Palo Alto Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIT0003AGG
  • R01DK118426 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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