Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

September 29, 2022 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

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hemodialysis patients who have residual kidney function will undergo two 4-week study (twice weekly versus thrice weekly hemodialysis). 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. Food records and medications may be monitored.

Study Type

Interventional

Enrollment (Anticipated)

50

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 Contact

Study Contact Backup

Study Locations

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stable dialysis patients able to provide consent

Exclusion Criteria:

  • Use of antibiotics for last two months or expected antibiotic use
  • Recent hospitalization or other event resulting in instability of food intake
  • Residual kidney function < 2.5 mL/min

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
Participants will undergo hemodialysis twice per week.
Other: Twice weekly hemodialysis
Effect of hemodialysis prescriptions of twice weekly versus thrice weekly on quality of life will be evaluated. All hemodialysis will be prescribed to achieve adequate treatment based on current National Kidney Foundation guidelines.
Other: Thrice weekly hemodialysis
Participants will undergo hemodialysis three times per week.
Other: Thrice weekly hemodialysis
Effect of hemodialysis prescriptions of twice weekly versus thrice weekly on quality of life will be evaluated. All hemodialysis will be prescribed to achieve adequate treatment based on current National Kidney Foundation guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QOL: KDQOL36
Time Frame: 4 weeks
Kidney Disease Quality of Life: Health-related quality of life. Physical component and Mental Components are measured on a scale of 0 to 100, with higher scores being better.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Solute Concentration
Time Frame: 4 weeks
mg/dl
4 weeks
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
Cognition
Time Frame: 4 weeks
Trail B Making Test
4 weeks
Cognition
Time Frame: 4 weeks
Digit Substitution Test
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

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 (Anticipated)

June 1, 2023

Study Completion (Anticipated)

December 1, 2023

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 (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

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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