Back to resultsEfficacy of Diuretics in Kidney Disease
Primary Purpose
Chronic Kidney Disease, End Stage Renal Disease
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metolazone
Placebo
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- stable chronic kidney disease patients able to provide consent
- stable dialysis patients who produce urine and 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
Sites / Locations
- Stanford University
- VA Palo Alto Health Care SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Metolazone then placebo
Placebo then Metolazone
Arm Description
Metolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week.
Placebo will be taken orally during the first week, followed by washout of 1-2 weeks, then metolazone will be taken the following week.
Outcomes
Primary Outcome Measures
Change in urine output
average volume of urine produced in 24 hours
Secondary Outcome Measures
Change in kidney clearance of uremic solutes
kidney clearance of uremic solutes in ml/min
Change in quality of life questionnaire score
Kidney Disease Quality of Life 36 Questionnaire (KDQOL36)
Full Information
NCT ID
NCT04542304
First Posted
August 27, 2020
Last Updated
September 29, 2022
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT04542304
Brief Title
Efficacy of Diuretics in Kidney Disease
Official Title
Efficacy of Diuretics in Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will determine the efficacy of diuretics in patients with chronic kidney disease.
Detailed Description
Participants with chronic kidney disease will undergo two 1-week study periods (diuretic versus placebo) separated by 1-2 weeks of washout in a cross-over design. Blood and urine samples will be collected at the end of each study period to determine the effect on urine output and to assess the kidney clearance and levels of uremic solute. Participants will weigh themselves daily and complete quality of life questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, End Stage Renal Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metolazone then placebo
Arm Type
Active Comparator
Arm Description
Metolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week.
Arm Title
Placebo then Metolazone
Arm Type
Placebo Comparator
Arm Description
Placebo will be taken orally during the first week, followed by washout of 1-2 weeks, then metolazone will be taken the following week.
Intervention Type
Drug
Intervention Name(s)
Metolazone
Intervention Description
Participants will be given a metolazone for the 1-week study period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will be given a placebo for the 1-week study period.
Primary Outcome Measure Information:
Title
Change in urine output
Description
average volume of urine produced in 24 hours
Time Frame
Change from baseline urine output at 1 week for each study arm
Secondary Outcome Measure Information:
Title
Change in kidney clearance of uremic solutes
Description
kidney clearance of uremic solutes in ml/min
Time Frame
Change from baseline kidney clearance of uremic solutes at 1 week for each study arm
Title
Change in quality of life questionnaire score
Description
Kidney Disease Quality of Life 36 Questionnaire (KDQOL36)
Time Frame
Change from baseline quality of life score at 1 week for each study arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable chronic kidney disease patients able to provide consent
stable dialysis patients who produce urine and 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tammy L Sirich, MD
Phone
650-493-5000
Ext
68321
Email
tsirich@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Sirich, MD
Phone
650-493-5000
Ext
68321
Email
tsirich@stanford.edu
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 Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Sirich, MD
Phone
650-493-5000
Ext
68321
Email
tsirich@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Diuretics in Kidney Disease
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