Efficacy of Diuretics in Kidney Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Stanford University
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- Change in Urine Output
Study Overview
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 (single-dose diuretic versus single-dose 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Metolazone then placebo
Metolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week.
Intervention: Placebo (Drug)
Placebo then Metolazone
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: Metolazone (Drug)
Metolazone then placebo
Metolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week.
Intervention: Metolazone (Drug)
Placebo then Metolazone
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: Placebo (Drug)
Outcomes
Primary Outcomes
Change in Urine Output
Time Frame: Change from baseline urine output at 1 week for each study arm
Average volume of urine produced in 24 hours.
Secondary Outcomes
- Plasma Urea(Week 1)
- Kidney Clearance of Uremic Solutes(Kidney clearance of uremic solutes at 1 week for each study arm)
- Change in Quality of Life Questionnaire Score(Change from baseline quality of life score at 1 week for each study arm)
- Blood Pressure(Week 1)
- Weight Change(Baseline, Week 1)
Investigators
Tammy Lisa Sirich
Assistant Professor of Medicine
Stanford University