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Completed

NCT Number: NCT03874117

Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Twice Weekly Hemodialysis then Thrice Weekly Hemodialysis

Other

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

Thrice Weekly Hemodialysis then Twice Weekly Hemodialysis

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Solute Concentration

    Time frame: 4 weeks

    Plasma concentration of p-cresol sulfate

  2. Symptom

    Time frame: 4 weeks

    Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.

  3. 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. Digit Symbol Substitution Test

    Time frame: 4 weeks

    Cognitive test: Digit Symbol Substitution Test, measured in number correct

Sponsors and collaborators

Lead sponsor

Palo Alto Veterans Institute for Research

Other

Collaborators

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

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Mar 14, 2019
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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