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Trial record 35 of 51 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

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ClinicalTrials.gov Identifier: NCT03874117
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Tammy Sirich, Palo Alto Veterans Institute for Research

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2018
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. QOL: KDQOL36 [ Time Frame: 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 [ Time Frame: 4 weeks ]
    mg/dl

  2. Symptom [ Time Frame: 4 weeks ]
    Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.

  3. Cognition [ Time Frame: 4 weeks ]
    Trail B Making Test

  4. Cognition [ Time Frame: 4 weeks ]
    Digit Substitution Test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874117


Contacts
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Contact: Tammy Sirich, MD 650-493-5000 ext 68321 tsirich@stanford.edu
Contact: Saniya Bonde, BS 650-493-5000 ext 64599 sbonde@stanford.edu

Locations
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United States, California
VA Palo Alto Health Care System Recruiting
Palo Alto, California, United States, 94304
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Satellite HealthCare Recruiting
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
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Principal Investigator: Tammy Sirich, MD Stanford/VA Palo Alto Health Care System

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Responsible Party: Tammy Sirich, Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT03874117     History of Changes
Other Study ID Numbers: SIT0003AGG
R01DK118426 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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