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Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

Primary Purpose

Hemodialysis, Kidney Failure, Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Twice weekly hemodialysis
Thrice weekly hemodialysis
Sponsored by
Palo Alto Veterans Institute for Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemodialysis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Palo Alto Health Care SystemRecruiting
  • Santa Clara Valley Medical CenterRecruiting
  • Satellite HealthCareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Twice weekly hemodialysis

Thrice weekly hemodialysis

Arm Description

Participants will undergo hemodialysis twice per week.

Participants will undergo hemodialysis three times per week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Solute Concentration
mg/dl
Symptom
Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
Cognition
Trail B Making Test
Cognition
Digit Substitution Test

Full Information

First Posted
March 10, 2019
Last Updated
September 29, 2022
Sponsor
Palo Alto Veterans Institute for Research
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03874117
Brief Title
Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
Official Title
Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Palo Alto Veterans Institute for Research
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis, Kidney Failure, Chronic

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Twice weekly hemodialysis
Arm Type
Other
Arm Description
Participants will undergo hemodialysis twice per week.
Arm Title
Thrice weekly hemodialysis
Arm Type
Other
Arm Description
Participants will undergo hemodialysis three times per week.
Intervention Type
Other
Intervention Name(s)
Twice weekly hemodialysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Thrice weekly hemodialysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
QOL: KDQOL36
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Solute Concentration
Description
mg/dl
Time Frame
4 weeks
Title
Symptom
Description
Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
Time Frame
4 weeks
Title
Cognition
Description
Trail B Making Test
Time Frame
4 weeks
Title
Cognition
Description
Digit Substitution Test
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy Sirich, MD
Phone
650-493-5000
Ext
68321
Email
tsirich@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Saniya Bonde, BS
Phone
650-493-5000
Ext
64599
Email
sbonde@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy Sirich, MD
Organizational Affiliation
Stanford/VA Palo Alto Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Name
Santa Clara Valley Medical Center
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Individual Site Status
Recruiting
Facility Name
Satellite HealthCare
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

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