Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

Not Applicable

Active, not recruiting

• Conditions: Kidney Failure, Chronic; Hemodialysis
• Interventions: Other: Twice weekly hemodialysis; Other: Thrice weekly 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). 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 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: 2024-04-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Twice weekly hemodialysis	Twice weekly hemodialysis	Participants will undergo hemodialysis twice per week.
Thrice weekly hemodialysis	Thrice weekly hemodialysis	Participants will undergo hemodialysis three times per week.

Primary Outcome Measures

Name	Time	Method
QOL: KDQOL36	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.

Secondary Outcome Measures

Name	Time	Method
Cognition	4 weeks	Digit Substitution Test
Symptom	4 weeks	Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
Solute Concentration	4 weeks	mg/dl

Trial Locations

Locations (3)

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

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

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