Efficacy of Diuretics in Kidney Disease

NCT ID: NCT04542304

Last Updated: 2025-06-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2023-06-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Kidney Disease End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Metolazone

Intervention Type DRUG

Participants receive a single dose of metolazone.

Placebo

Intervention Type DRUG

Participants receive a single dose of placebo to match metolazone.

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.

Group Type PLACEBO_COMPARATOR

Metolazone

Intervention Type DRUG

Participants receive a single dose of metolazone.

Placebo

Intervention Type DRUG

Participants receive a single dose of placebo to match metolazone.

Interventions

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Metolazone

Participants receive a single dose of metolazone.

Intervention Type DRUG

Placebo

Participants receive a single dose of placebo to match metolazone.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Tammy Lisa Sirich

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Palo Alto, California, United States

Site Status

VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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56566

Identifier Type: -

Identifier Source: org_study_id

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