Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

• Sponsor: Palo Alto Veterans Institute for Research (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03874117
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 50
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 65
• Patients Per Site: 16.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis; Kidney Failure, Chronic	Other: Twice weekly hemodialysis; Other: Thrice weekly hemodialysis	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
• Actual Study Start Date: Jul 1, 2018
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Solute Concentration [4 weeks]

   mg/dl

2. Symptom [4 weeks]

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

3. Cognition [4 weeks]

   Trail B Making Test

4. Cognition [4 weeks]

   Digit Substitution Test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System	Palo Alto	California	United States	94304
2	Santa Clara Valley Medical Center	San Jose	California	United States	95128
3	Satellite HealthCare	San Jose	California	United States	95128

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Tammy Sirich, MD, Stanford/VA Palo Alto Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tammy Sirich, Principal Investigator, Palo Alto Veterans Institute for Research
• ClinicalTrials.gov Identifier: NCT03874117
• Other Study ID Numbers: SIT0003AGG; R01DK118426
• First Posted: Mar 14, 2019
• Last Update Posted: Apr 29, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic

Study Results

No Results Posted as of Apr 29, 2021