Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

Not Applicable

Completed

• Conditions: Kidney Failure, Chronic; Hemodialysis

• Registration Number: NCT03874117
• Lead Sponsor: Palo Alto Veterans Institute for Research

Brief Summary

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

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 Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-14
• Primary Completion: 2024-09-01
• Study Completion: 2025-05-31
• Results First Submitted: 2025-07-07
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Results First Posted: 2025-09-03
• Last Update Posted: 2025-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Solute Concentration	4 weeks	Plasma concentration of p-cresol sulfate
Symptom	4 weeks	Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
Trail B Making Test	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.
Digit Symbol Substitution Test	4 weeks	Cognitive test: Digit Symbol Substitution Test, measured in number correct

Trial Locations

Locations (3)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

Santa Clara Valley Medical Center; 🇺🇸 San Jose, California, United States

Satellite HealthCare; 🇺🇸 San Jose, California, United States