Nephrotic SyndromePhase 3AMILORNCT05079789
Amiloride in Nephrotic Syndrome
A Phase 3 study testing Amiloride and Furosemide in people with Nephrotic Syndrome and Edema, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The AMILOR study compares treatment of edema in nephrotic syndrome with Amiloride vs. Furosemide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrotic Syndrome, Edema, Sodium Retention
- What is being tested?
- Amiloride and Furosemide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jun 2020to 20 Nov 2022
- Phase
- Phase 3
- 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
- Acute nephrotic syndrome with proteinuria > 3 g/day and formation of edema.
- Age ≥ 18 years at the time of signing the informed consent.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Use of adequate thrombosis prophylaxis due to the increased risk of thrombosis in nephrotic syndrome and the expected fluctuations in volume balance during study participation.
- Subject (male or female) is willing to use highly effective methods of contraception according to the "Clinical trial fertility group" recommendations.
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- Female Patients of childbearing potential (WOCBP) must agree to pregnancy testing before inclusion in the study.
- Female Patients must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation.
- All subjects must agree not to share medication.
Who cannot join
- Severe reduction of kidney function: Creatinine clearance or calculated GFR < 30 mL/min/1.73m² or acute kidney injury KDIGO stage 2 or 3 or anuria.
- Hypovolemia or dehydration.
- Uncontrolled diabetes mellitus.
- Hypotension, systolic blood pressure < 90 mmHg.
- Hyperkalemia, plasma potassium concentration > 4.8 mmol/l.
- Hypokalemia, plasma potassium concentration < 3.3 mmol/l.
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- Hyponatremia, plasma sodium concentration < 128 mmol/l.
- Hypercalcemia, ionized calcium > 2.0 mmol/l or total albumin corrected calcium > 3.0 mmol/l.
- Signs of cardiac decompensation (orthopnoe, dyspnoe NYHA IV).
- Hepatic coma or precoma.
- Symptoms of gout.
- Current therapy with potassium-sparing diuretics (e.g. spironolactone) or potassium supplements.
- Women during pregnancy and lactation.
- History of hypersensitivity to the investigational medicinal product, comparator or co-medication or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product, comparator or co-medication.
- Any other clinical condition that would jeopardize the patient's safety while participating in this clinical trial.
- Active participation in other clinical trials or observation period of competing trials.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Randomized, Controlled Interventional Trial to Investigate the Efficacy of Amiloride for the Treatment of Edema in Human Nephrotic Syndrome
The AMILOR study compares treatment of edema in nephrotic syndrome with Amiloride vs. Furosemide.
Read the detailed description
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.
- Conditions
- Nephrotic Syndrome, Edema, Sodium Retention
- Being tested
- Amiloride, Furosemide
- Keywords
- Nephrotic Syndrome, ENaC, Diuretic therapy, Amiloride, Proteasuria
- Medical subject headings
- Nephrotic Syndrome, Edema, Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmilorideDrug
Treatment with amiloride, start dose 5 mg
FurosemideDrug
Treatment with furosemide, start dose 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Amiloride | Experimental | Treatment wirh Amiloride, start dose 5 mg Receives: Drug: Amiloride |
| Furosemide | Active comparator | Treatment with Furosemide, start dose 40 mg Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of Overhydration, %ECW After 8 Days
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Measured: 8 days
Secondary outcomes (2)
Decrease of Overhydration, %ECW After 16 Days
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
Measured: 16 days
Decrease of Body Weight, kg
Decrease of body weight after 8 days
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start8 Jun 2020
- Primary completion5 Nov 2022
- Study completion20 Nov 2022
Why it stopped: Low recruiting rate and decision to evaluate as pilot study
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nephrotic SyndromeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Anja Schork, University Hospital Tuebingen
- Investigators
- Ferruh Artunc, Prof., MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079789
- Sponsor's protocol ID
- AmiloridNS-01
- Other IDs
- 2019-002607-18, 2019
- Acronym
- AMILOR
- Status last verified
- Jan 2025
- First submitted
- 2 Oct 2021
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Artunc F, Worn M, Schork A, Bohnert BN. Proteasuria-The impact of active urinary proteases on sodium retention in nephrotic syndrome. Acta Physiol (Oxf). 2019 Apr;225(4):e13249. doi: 10.1111/apha.13249. Epub 2019 Jan 18.
PubMed 30597733
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Interventional Trial to Investigate the Efficacy of Amiloride for the Treatment of Edema in Human Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT05079789
- Acronym / sponsor ID
- AMILOR / AmiloridNS-01
- Conditions
- Nephrotic Syndrome, Edema, Sodium Retention
- Keywords
- Nephrotic Syndrome, ENaC, Diuretic therapy, Amiloride, Proteasuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruiting rate and decision to evaluate as pilot study
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 5 Nov 2022 (actual)
- Study completion
- 20 Nov 2022 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The AMILOR study compares treatment of edema in nephrotic syndrome with Amiloride vs. Furosemide.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiloride | Experimental | Drug: AmilorideTreatment wirh Amiloride, start dose 5 mg |
| Furosemide | Active comparator | Drug: FurosemideTreatment with Furosemide, start dose 40 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Acute nephrotic syndrome with proteinuria > 3 g/day and formation of edema.
- Age ≥ 18 years at the time of signing the informed consent.
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Use of adequate thrombosis prophylaxis due to the increased risk of thrombosis in nephrotic syndrome and the expected fluctuations in volume balance during study participation.
Key exclusion criteria (16 listed)
- Severe reduction of kidney function: Creatinine clearance or calculated GFR < 30 mL/min/1.73m² or acute kidney injury KDIGO stage 2 or 3 or anuria.
- Hypovolemia or dehydration.
- Uncontrolled diabetes mellitus.
- Hypotension, systolic blood pressure < 90 mmHg.
- Hyperkalemia, plasma potassium concentration > 4.8 mmol/l.
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 |
|---|---|---|
| AmilorideTreatment with amiloride, start dose 5 mg | Drug | Amiloride |
| FurosemideTreatment with furosemide, start dose 40 mg | Drug | Furosemide |
Primary outcome
Decrease of Overhydration, %ECW After 8 Days
Time frame: 8 days
Decrease of overhydration (OH) measured by bioimpedance spectroscopy, expressed as percent of extracellular water (%ECW)
2 secondary outcomes
Decrease of Overhydration, %ECW After 16 Days
Time frame: 16 days
Decrease of Body Weight, kg
Time frame: 8 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30597733Artunc F, Worn M, Schork A, Bohnert BN. Proteasuria-The impact of active urinary proteases on sodium retention in nephrotic syndrome. Acta Physiol (Oxf). 2019 Apr;225(4):e13249. doi: 10.1111/apha.13249. Epub 2019 Jan 18.
- Homepage working group Prof. ArtuncLink provided by the sponsor.
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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.
Ferruh Artunc, Prof., MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiloride and Furosemide in people with Nephrotic Syndrome and Edema, run by University Hospital Tuebingen at 1 site in Germany.
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 9 inclusion and 16 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 14 Jan 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?
Decrease of Overhydration, %ECW After 8 Days (time frame: 8 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079789, which also lists 1 linked publication.
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 14 Jan 2025.