Efficacy of Diuretics in Kidney Disease

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

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease; Chronic Kidney Disease
• Intervention / Treatment: Drug: Metolazone; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tammy L Sirich, MD; Phone Number: 68321 650-493-5000; Email: tsirich@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • VA Palo Alto Health Care System
      • Contact: Tammy Sirich, MD; Phone Number: 68321 650-493-5000; Email: tsirich@stanford.edu
    • Palo Alto, California, United States, 94304
      • Not yet recruiting
      • Stanford University
      • Contact: Tammy Sirich, MD; Phone Number: 68321 650-493-5000; Email: tsirich@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Metolazone; Participants will be given a metolazone for the 1-week study period.
Placebo Comparator: 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.	Drug: Placebo; Participants will be given a placebo for the 1-week study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Sodium Chloride Symporter Inhibitors; Metolazone
• Other Study ID Numbers: 56566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No