Chronic Kidney DiseasePhase 2NCT04542304
Efficacy of Diuretics in Kidney Disease
A Phase 2 study testing Metolazone in people with Chronic Kidney Disease and End Stage Renal Disease, run by Stanford University at 2 sites in United States.
Trial summary
This study will determine the efficacy of diuretics in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, End Stage Renal Disease
- What is being tested?
- Metolazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2021to 15 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable chronic kidney disease patients able to provide consent
- stable dialysis patients who produce urine and able to provide consent
Who cannot join
- use of antibiotics for last two months or expected antibiotic use
- recent hospitalization or other event resulting in instability of food intake
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University
Palo Alto, California, 94304
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
This study will determine the efficacy of diuretics in patients with chronic kidney disease.
Read the 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.
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Being tested
- Metolazone, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetolazoneDrug
Participants receive a single dose of metolazone.
PlaceboDrug
Participants receive a single dose of placebo to match metolazone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Metolazone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urine Output
Average volume of urine produced in 24 hours.
Measured: 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 in ml/min.
Measured: 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)
Measured: Change from baseline quality of life score at 1 week for each study arm
Plasma Urea
Measured: Week 1
Blood Pressure
Measured: Week 1
Weight Change
Measured: Baseline, Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Mar 2021
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Why it stopped: Lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tammy Lisa Sirich, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542304
- Sponsor's protocol ID
- 56566
- Status last verified
- May 2025
- First submitted
- 27 Aug 2020
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diuretics in Kidney Disease
- ClinicalTrials.gov ID
- NCT04542304
- Acronym / sponsor ID
- 56566
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 9 Sep 2020 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metolazone then placebo | Active comparator | Drug: Metolazone, Drug: PlaceboMetolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week. |
| Placebo then Metolazone | Placebo comparator | Drug: Metolazone, Drug: PlaceboPlacebo will be taken orally during the first week, followed by washout of 1-2 weeks, then metolazone will be taken the following week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stable chronic kidney disease patients able to provide consent
- stable dialysis patients who produce urine and able to provide consent
Key exclusion criteria (2 listed)
- use of antibiotics for last two months or expected antibiotic use
- recent hospitalization or other event resulting in instability of food intake
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetolazoneParticipants receive a single dose of metolazone. | Drug | Metolazone then placebo, Placebo then Metolazone |
| PlaceboParticipants receive a single dose of placebo to match metolazone. | Drug | Metolazone then placebo, Placebo then Metolazone |
Primary outcome
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.
5 secondary outcomes
Kidney Clearance of Uremic Solutes
Time frame: Kidney clearance of uremic solutes at 1 week for each study arm
Change in Quality of Life Questionnaire Score
Time frame: Change from baseline quality of life score at 1 week for each study arm
Plasma Urea
Time frame: Week 1
Blood Pressure
Time frame: Week 1
Weight Change
Time frame: Baseline, Week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metolazone in people with Chronic Kidney Disease and End Stage Renal Disease, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urine Output (time frame: Change from baseline urine output at 1 week for each study arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.