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NCT04542304 Clinical Trial

Efficacy of Diuretics in Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:
Efficacy of Diuretics in Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04542304
Other study ID # 56566
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date July 2024

Study information
Verified date September 2022
Source Stanford University
Contact Tammy L Sirich, MD
Phone 650-493-5000
Email tsirich@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will determine the efficacy of diuretics in patients with chronic kidney disease.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Metolazone
Participants will be given a metolazone for the 1-week study period.
• Placebo
Participants will be given a placebo for the 1-week study period.

Locations
Country Name City State
United States Stanford University Palo Alto California
United States VA Palo Alto Health Care System Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in urine output average volume of urine produced in 24 hours Change from baseline urine output at 1 week for each study arm
Secondary Change in kidney clearance of uremic solutes kidney clearance of uremic solutes in ml/min Change from baseline kidney clearance of uremic solutes at 1 week for each study arm
Secondary Change in quality of life questionnaire score Kidney Disease Quality of Life 36 Questionnaire (KDQOL36) Change from baseline quality of life score at 1 week for each study arm
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