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Trial record 33 of 51 for:    Recruiting, Not yet recruiting, Available Studies | kidney disease | NIDDK

Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03874117
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : March 15, 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

Tracking Information
First Submitted Date  ICMJE March 10, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 15, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
QOL: KDQOL36 [ Time Frame: 4 weeks ]
KDQOL36
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Solute Concentration [ Time Frame: 4 weeks ]
    mg/dl
  • Symptom [ Time Frame: 4 weeks ]
    Dialysis Symptom Index: measures symptom burden on a scale of 0 to 150, with higher scores being worse.
  • Cognition [ Time Frame: 4 weeks ]
    Trail B Making Test
  • Cognition [ Time Frame: 4 weeks ]
    Digit Substitution Test
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Solute Concentration [ Time Frame: 4 weeks ]
    mg/dl
  • Symptom [ Time Frame: 4 weeks ]
    Dialysis Symptom Index
  • Cognition [ Time Frame: 4 weeks ]
    Trail B Making Test
  • Cognition [ Time Frame: 4 weeks ]
    Digit Substitution Test
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
Official Title  ICMJE Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Hemodialysis
  • Kidney Failure, Chronic
Intervention  ICMJE
  • 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
    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.
Study Arms  ICMJE
  • Twice weekly hemodialysis
    Participants will undergo hemodialysis twice per week.
    Intervention: Other: Twice weekly hemodialysis
  • Thrice weekly hemodialysis
    Participants will undergo hemodialysis three times per week.
    Intervention: Other: Thrice weekly hemodialysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tammy Sirich, MD 650-493-5000 ext 68321 tsirich@stanford.edu
Contact: Saniya Bonde, BS 650-493-5000 ext 64599 sbonde@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03874117
Other Study ID Numbers  ICMJE SIT0003AGG
R01DK118426 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tammy Sirich, Palo Alto Veterans Institute for Research
Study Sponsor  ICMJE Palo Alto Veterans Institute for Research
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Tammy Sirich, MD Stanford/VA Palo Alto Health Care System
PRS Account Palo Alto Veterans Institute for Research
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP