Trial Outcomes & Findings for Efficacy of Diuretics in Kidney Disease (NCT NCT04542304)
NCT ID: NCT04542304
Last Updated: 2025-06-05
Results Overview
Average volume of urine produced in 24 hours.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Change from baseline urine output at 1 week for each study arm
Results posted on
2025-06-05
Participant Flow
17 participants signed informed consent, and 6 were randomized to treatment.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Treatment Period 1 (1 Week)
STARTED
|
3
|
3
|
|
Treatment Period 1 (1 Week)
COMPLETED
|
3
|
3
|
|
Treatment Period 1 (1 Week)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (2 Weeks)
STARTED
|
3
|
3
|
|
Washout Period (2 Weeks)
COMPLETED
|
3
|
3
|
|
Washout Period (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (1 Week)
STARTED
|
3
|
3
|
|
Treatment Period 2 (1 Week)
COMPLETED
|
3
|
3
|
|
Treatment Period 2 (1 Week)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Diuretics in Kidney Disease
Baseline characteristics by cohort
| Measure |
Metolazone Then Placebo
n=3 Participants
Metolazone single dose taken orally during the first week, followed by washout of 1-2 weeks, then placebo single dose taken the following week.
|
Placebo Then Metolazone
n=3 Participants
Placebo single dose taken orally during the first week, followed by washout of 1-2 weeks, then metolazone single dose taken the following week.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
66 years
STANDARD_DEVIATION 13 • n=7 Participants
|
66 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline urine output at 1 week for each study armAverage volume of urine produced in 24 hours.
Outcome measures
| Measure |
Metolazone
n=6 Participants
Metolazone (single dose)
|
Placebo
n=6 Participants
Placebo (single dose)
|
|---|---|---|
|
Change in Urine Output
|
809 mL/day
Standard Deviation 466
|
676 mL/day
Standard Deviation 487
|
SECONDARY outcome
Timeframe: Kidney clearance of uremic solutes at 1 week for each study armKidney clearance of uremic solutes in ml/min.
Outcome measures
| Measure |
Metolazone
n=6 Participants
Metolazone (single dose)
|
Placebo
n=6 Participants
Placebo (single dose)
|
|---|---|---|
|
Kidney Clearance of Uremic Solutes
P-Cresol sulfate
|
15 mL/min
Standard Deviation 11
|
10 mL/min
Standard Deviation 8
|
|
Kidney Clearance of Uremic Solutes
Indoxyl sulfate
|
34 mL/min
Standard Deviation 20
|
22 mL/min
Standard Deviation 15
|
|
Kidney Clearance of Uremic Solutes
Hippurate
|
61 mL/min
Standard Deviation 48
|
42 mL/min
Standard Deviation 29
|
|
Kidney Clearance of Uremic Solutes
Phenylactyl glutamine
|
14 mL/min
Standard Deviation 9
|
9 mL/min
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Change from baseline quality of life score at 1 week for each study armPopulation: 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.
Kidney Disease Quality of Life 36 Questionnaire (KDQOL36)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 1Outcome measures
| Measure |
Metolazone
n=6 Participants
Metolazone (single dose)
|
Placebo
n=6 Participants
Placebo (single dose)
|
|---|---|---|
|
Plasma Urea
|
54 mg/dL
Standard Deviation 15
|
54 mg/dL
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Week 1Outcome measures
| Measure |
Metolazone
n=6 Participants
Metolazone (single dose)
|
Placebo
n=6 Participants
Placebo (single dose)
|
|---|---|---|
|
Blood Pressure
Systolic
|
140 mmHg
Standard Deviation 25
|
146 mmHg
Standard Deviation 18
|
|
Blood Pressure
Diastolic
|
77 mmHg
Standard Deviation 13
|
76 mmHg
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Baseline, Week 1Outcome measures
| Measure |
Metolazone
n=6 Participants
Metolazone (single dose)
|
Placebo
n=6 Participants
Placebo (single dose)
|
|---|---|---|
|
Weight Change
Baseline
|
74 kg
Standard Deviation 30
|
73 kg
Standard Deviation 31
|
|
Weight Change
Week 1
|
1.6 kg
Standard Deviation 1.7
|
1.9 kg
Standard Deviation 1.7
|
Adverse Events
Metolazone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER