Efficacy of Diuretics in Kidney Disease

Phase 2

Recruiting

• Conditions: Chronic Kidney Disease; End Stage Renal Disease
• Interventions: Drug: Placebo; Drug: Metolazone

• Registration Number: NCT04542304
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2020-08-27
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2021-03-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03
• Primary Completion: 2024-07
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo then Metolazone	Placebo	Placebo will be taken orally during the first week, followed by washout of 1-2 weeks, then metolazone will be taken the following week.
Metolazone then placebo	Metolazone	Metolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week.

Primary Outcome Measures

Name	Time	Method
Change in urine output	Change from baseline urine output at 1 week for each study arm	average volume of urine produced in 24 hours

Secondary Outcome Measures

Name	Time	Method
Change in kidney clearance of uremic solutes	Change from baseline kidney clearance of uremic solutes at 1 week for each study arm	kidney clearance of uremic solutes in ml/min
Change in quality of life questionnaire score	Change from baseline quality of life score at 1 week for each study arm	Kidney Disease Quality of Life 36 Questionnaire (KDQOL36)

Trial Locations

Locations (2)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States