A Phase 3 interventional study of Amiloride and Furosemide in Nephrotic Syndrome, Edema and Sodium Retention, sponsored by University Hospital Tuebingen. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by University Hospital Tuebingen · Phase 3, Interventional, and Treatment
The AMILOR study compares treatment of edema in nephrotic syndrome with Amiloride vs. Furosemide.
The monocenter randomized-controlled AMILOR trial investigates the efficacy of the ENaC blocker amiloride in reducing edema in nephrotic syndrome compared with standard therapy with the loop diuretic furosemide.
Patients with acute nephrotic syndrome are randomized to receive amiloride (starting dose 5 mg) or furosemide (starting dose 40 mg) for 16 days. The target number of patients is n = 18 per arm. Exclusion criteria include GFR \<30ml/min/1.73m², AKIN 1 and 2, hypotension, hyper-/ hypokalemia, and hyponatremia. Overhydration is quantified by bioimpedance spectroscopy. Depending on the course of overhydration, dose adjustments (day 2, 5, 8, 12) or addition of HCT (day 8) are performed during the course of the study.
Primary endpoint is decrease in overhydration at day 8, secondary endpoints include decrease in overhydration at day 16, as well as body weight, edema volume, blood pressure, urine volume, natriuresis at day 8 and 16, and need for dose adjustments and co-medication with HCT. Plasma potassium, sodium, and creatinine concentrations are measured as safety parameters.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's enrollment of 20 is below the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →University Hospital Tuebingen is the lead sponsor of 490 studies on the registry; 108 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment wirh Amiloride, start dose 5 mg
Drug: Amiloride
Treatment with Furosemide, start dose 40 mg
Drug: Furosemide
Treatment with amiloride, start dose 5 mg
Treatment with furosemide, start dose 40 mg
Decrease of Overhydration, %ECW After 8 Days
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Time frame: 8 days
Decrease of Overhydration, %ECW After 16 Days
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Time frame: 16 days
Decrease of Body Weight, kg
Decrease of body weight after 8 days
Time frame: 8 days
| Milestone | Amiloride | Furosemide |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
| %ECW | Amiloride | Furosemide |
|---|---|---|
| Decrease of Overhydration, %ECW After 8 Days | 1.95 (0.80 to 6.40) | 5.15 (0.90 to 8.30) |
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
| %ECW | Amiloride | Furosemide |
|---|---|---|
| Decrease of Overhydration, %ECW After 16 Days | 10.10 (1.30 to 14.40) | 7.40 (2.80 to 10.10) |
Decrease of body weight after 8 days
| kg | Amiloride | Furosemide |
|---|---|---|
| Decrease of Body Weight, kg | 3.8 (1.7 to 7.2) | 2.0 (1.5 to 4.6) |
Collected over 23 days for everey subject. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Amiloride | 0/10 (0%) | 1/10 (10%) | 9/10 (90%) |
| Furosemide | 0/10 (0%) | 4/10 (40%) | 10/10 (100%) |
| Event | Amiloride | Furosemide |
|---|---|---|
| delayed discharge from hospital due to macrohematuria after kidneybiopsySurgical and medical procedures | 1/10 | 0/10 |
| myocardial infarctionCardiac disorders | 0/10 | 1/10 |
| pericardial effusion with in-hospital monitoringCardiac disorders | 0/10 | 1/10 |
| abdominal pain with diarrhea with inhospital treatmentGastrointestinal disorders | 0/10 | 1/10 |
| AKI stage 2 with in-hospital treatmentRenal and urinary disorders | 0/10 | 1/10 |
| Event | Amiloride | Furosemide |
|---|---|---|
| planned hospitalization for kidney biopsySurgical and medical procedures | 2/10 | 3/10 |
| nauseaGastrointestinal disorders | 2/10 | 0/10 |
| SARS CoV 2 infectionInfections and infestations | 2/10 | 1/10 |
| dizzinessNervous system disorders | 0/10 | 1/10 |
| headacheNervous system disorders | 0/10 | 1/10 |
| epistaxisRespiratory, thoracic and mediastinal disorders | 1/10 | 1/10 |
| elevated liver enzymesHepatobiliary disorders | 0/10 | 1/10 |
| rashSkin and subcutaneous tissue disorders | 0/10 | 1/10 |
| urinary infectionRenal and urinary disorders | 1/10 | 0/10 |
| hypervolemia (worsening)Renal and urinary disorders | 1/10 | 0/10 |
| Age, Categorical(Participants) | Amiloride | Furosemide | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 8 | 16 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | Amiloride | Furosemide | Total |
|---|---|---|---|
| Median | 51 (46 to 53) | 50 (25 to 58) | 51 (36 to 55) |
| Sex: Female, Male(Participants) | Amiloride | Furosemide | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 5 | 8 | 13 |
| Race/Ethnicity, Customized(Participants) | Amiloride | Furosemide | Total |
|---|---|---|---|
| Ethnicity — European | 9 | 10 | 19 |
| Ethnicity — Indian | 1 | 0 | 1 |
| Region of Enrollment(participants) | Amiloride | Furosemide | Total |
|---|---|---|---|
| Germany | 10 | 10 | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amiloride
University Hospital Tuebingen →