Trial Outcomes & Findings for Amiloride in Nephrotic Syndrome (NCT NCT05079789)
NCT ID: NCT05079789
Last Updated: 2025-01-14
Results Overview
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
8 days
Results posted on
2025-01-14
Participant Flow
Participant milestones
| Measure |
Amiloride
Treatment wirh Amiloride, start dose 5 mg
Amiloride: Treatment with amiloride, start dose 5 mg
|
Furosemide
Treatment with Furosemide, start dose 40 mg
Furosemide: Treatment with furosemide, start dose 40 mg
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amiloride in Nephrotic Syndrome
Baseline characteristics by cohort
| Measure |
Amiloride
n=10 Participants
Treatment wirh Amiloride, start dose 5 mg
Amiloride: Treatment with amiloride, start dose 5 mg
|
Furosemide
n=10 Participants
Treatment with Furosemide, start dose 40 mg
Furosemide: Treatment with furosemide, start dose 40 mg
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
n=5 Participants
|
50 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · European
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Indian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 daysDecrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Outcome measures
| Measure |
Amiloride
n=10 Participants
Treatment wirh Amiloride, start dose 5 mg
Amiloride: Treatment with amiloride, start dose 5 mg
|
Furosemide
n=10 Participants
Treatment with Furosemide, start dose 40 mg
Furosemide: Treatment with furosemide, start dose 40 mg
|
|---|---|---|
|
Decrease of Overhydration, %ECW After 8 Days
|
1.95 %ECW
Interval 0.8 to 6.4
|
5.15 %ECW
Interval 0.9 to 8.3
|
SECONDARY outcome
Timeframe: 16 daysDecrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Outcome measures
| Measure |
Amiloride
n=9 Participants
Treatment wirh Amiloride, start dose 5 mg
Amiloride: Treatment with amiloride, start dose 5 mg
|
Furosemide
n=10 Participants
Treatment with Furosemide, start dose 40 mg
Furosemide: Treatment with furosemide, start dose 40 mg
|
|---|---|---|
|
Decrease of Overhydration, %ECW After 16 Days
|
10.10 %ECW
Interval 1.3 to 14.4
|
7.40 %ECW
Interval 2.8 to 10.1
|
SECONDARY outcome
Timeframe: 8 daysDecrease of body weight after 8 days
Outcome measures
| Measure |
Amiloride
n=10 Participants
Treatment wirh Amiloride, start dose 5 mg
Amiloride: Treatment with amiloride, start dose 5 mg
|
Furosemide
n=10 Participants
Treatment with Furosemide, start dose 40 mg
Furosemide: Treatment with furosemide, start dose 40 mg
|
|---|---|---|
|
Decrease of Body Weight, kg
|
3.8 kg
Interval 1.7 to 7.2
|
2.0 kg
Interval 1.5 to 4.6
|
Adverse Events
Amiloride
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Furosemide
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amiloride
n=10 participants at risk
Treatment wirh Amiloride, start dose 5 mg
Amiloride: Treatment with amiloride, start dose 5 mg
|
Furosemide
n=10 participants at risk
Treatment with Furosemide, start dose 40 mg
Furosemide: Treatment with furosemide, start dose 40 mg
|
|---|---|---|
|
Surgical and medical procedures
delayed discharge from hospital due to macrohematuria after kidneybiopsy
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
0.00%
0/10 • 23 days for everey subject
|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Cardiac disorders
pericardial effusion with in-hospital monitoring
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Gastrointestinal disorders
abdominal pain with diarrhea with inhospital treatment
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Renal and urinary disorders
AKI stage 2 with in-hospital treatment
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
Other adverse events
| Measure |
Amiloride
n=10 participants at risk
Treatment wirh Amiloride, start dose 5 mg
Amiloride: Treatment with amiloride, start dose 5 mg
|
Furosemide
n=10 participants at risk
Treatment with Furosemide, start dose 40 mg
Furosemide: Treatment with furosemide, start dose 40 mg
|
|---|---|---|
|
Surgical and medical procedures
planned hospitalization for kidney biopsy
|
20.0%
2/10 • Number of events 2 • 23 days for everey subject
|
30.0%
3/10 • Number of events 3 • 23 days for everey subject
|
|
Nervous system disorders
dizziness
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Nervous system disorders
headache
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Gastrointestinal disorders
nausea
|
20.0%
2/10 • Number of events 2 • 23 days for everey subject
|
0.00%
0/10 • 23 days for everey subject
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Hepatobiliary disorders
elevated liver enzymes
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Renal and urinary disorders
urinary infection
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
0.00%
0/10 • 23 days for everey subject
|
|
Renal and urinary disorders
hypervolemia (worsening)
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
0.00%
0/10 • 23 days for everey subject
|
|
Infections and infestations
SARS CoV 2 infection
|
20.0%
2/10 • Number of events 2 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
|
Musculoskeletal and connective tissue disorders
cramps of legs and hands
|
0.00%
0/10 • 23 days for everey subject
|
10.0%
1/10 • Number of events 1 • 23 days for everey subject
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place