Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

Hemodialysis Clinical Trial

Official title:

Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03874117
• Other study ID #: SIT0003AGG
• Secondary ID: R01DK118426
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Palo Alto Veterans Institute for Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Palo Alto Veterans Institute for Research	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QOL: KDQOL36	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	Solute Concentration	mg/dl	4 weeks
Secondary	Symptom	Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.	4 weeks
Secondary	Cognition	Trail B Making Test	4 weeks
Secondary	Cognition	Digit Substitution Test	4 weeks