Efficacy of Diuretics in Kidney Disease

NCT04542304 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 56566
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Kidney Disease; End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Plasma Urea

  Week 1

• Blood Pressure

  Week 1

• Weight Change

  Baseline, Week 1

Study Arms (2)

Metolazone then placebo

ACTIVE COMPARATOR

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; Drug: Placebo

Placebo then Metolazone

PLACEBO COMPARATOR

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: Metolazone; Drug: Placebo

Interventions

Metolazone DRUG

Participants receive a single dose of metolazone.

Metolazone then placebo; Placebo then Metolazone

Placebo DRUG

Participants receive a single dose of placebo to match metolazone.

Metolazone then placebo; Placebo then Metolazone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stable chronic kidney disease patients able to provide consent
• stable dialysis patients who produce urine and able to provide consent

You may not qualify if:

• use of antibiotics for last two months or expected antibiotic use
• recent hospitalization or other event resulting in instability of food intake

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford University

Palo Alto, California, 94304, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Metolazone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Quinazolinones; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination led to a small number of participants analyzed.

Results Point of Contact

• Title: Tammy Lisa Sirich, MD
• Organization: Stanford University

tsirich@stanford.edu

650-849-1907

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 9, 2020
• Study Start: March 1, 2021
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)