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Lack of resources
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This study will determine the efficacy of diuretics in patients with chronic kidney disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metolazone | Drug | Participants receive a single dose of metolazone. |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Kidney Clearance of Uremic Solutes | Kidney clearance of uremic solutes in ml/min. | Kidney clearance of uremic solutes at 1 week for each study arm |
| Change in Quality of Life Questionnaire Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States | ||
| VA Palo Alto Health Care System |
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17 participants signed informed consent, and 6 were randomized to treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Metolazone Then Placebo | Metolazone single dose taken orally during the first week, followed by washout of 1-2 weeks, then placebo single dose taken the following week. |
| FG001 | Placebo Then Metolazone | Placebo single dose taken orally during the first week, followed by washout of 1-2 weeks, then metolazone single dose taken the following week. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 (1 Week) |
| |||||||||||||
| Washout Period (2 Weeks) |
| |||||||||||||
| Treatment Period 2 (1 Week) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metolazone Then Placebo | Metolazone single dose taken orally during the first week, followed by washout of 1-2 weeks, then placebo single dose taken the following week. |
| BG001 | Placebo Then Metolazone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Urine Output | Average volume of urine produced in 24 hours. | Posted | Mean | Standard Deviation | mL/day | Change from baseline urine output at 1 week for each study arm |
|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metolazone | Metolazone (single dose) | 0 |
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Early termination led to a small number of participants analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy Lisa Sirich, MD | Stanford University | 650-849-1907 | tsirich@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2023 | Apr 17, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2025 | Apr 14, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008788 | Metolazone |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug | Participants receive a single dose of placebo to match metolazone. |
|
Kidney Disease Quality of Life 36 Questionnaire (KDQOL36)
| 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 |
| Palo Alto |
| California |
| 94304 |
| United States |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
Placebo single dose taken orally during the first week, followed by washout of 1-2 weeks, then metolazone single dose taken the following week.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Kidney Clearance of Uremic Solutes | Kidney clearance of uremic solutes in ml/min. | Posted | Mean | Standard Deviation | mL/min | Kidney clearance of uremic solutes at 1 week for each study arm |
|
|
|
| Secondary | Change in Quality of Life Questionnaire Score | Kidney Disease Quality of Life 36 Questionnaire (KDQOL36) | Because the plan was to administer the intervention as a single dose, the investigators determined that the KDQOL should be removed from the study design because it is an evaluation used to assess changes over time. This decision was made prior to enrollment of any participants and was not administered to any study participants; however, the measure was not removed from the registration at that time. | Posted | Change from baseline quality of life score at 1 week for each study arm |
|
|
| Secondary | Plasma Urea | Posted | Mean | Standard Deviation | mg/dL | Week 1 |
|
|
|
| Secondary | Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Week 1 |
|
|
|
| Secondary | Weight Change | Posted | Mean | Standard Deviation | kg | Baseline, Week 1 |
|
|
|
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo | Placebo (single dose) | 0 | 6 | 0 | 6 | 0 | 6 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D052999 | Quinazolinones |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Hippurate |
|
| Phenylactyl glutamine |
|