Chronic Kidney Disease(CKD)Phase 2A-CKDNCT06923709
Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease
A Phase 2 study testing amiloride in people with Chronic Kidney Disease(CKD) and Proteinuria, run by Odense University Hospital at 1 site in Denmark.
Trial summary
This is a randomized, placebo-controlled, double-blinded crossover trial testing the effects of amiloride in patients with chronic kidney disease (CKD) and proteinuria. In CKD with proteinuria, there is aberrant filtration of serine proteases and complement precursors into the tubular lumen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease(CKD), Proteinuria
- What is being tested?
- amiloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2024to 1 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants are eligible to be included in the study, only if all the following criteria apply:
- Participant must be 18 years of age including at the time of signing the informed consent.
- A clinical diagnosis of chronic kidney disease and:
- eGFR ≥ 25 mL/min/1.73m2 and < 60mL/ min/1.73m2 at screening
- UACR of ≥ 300mg/g at screening
- Participants must be on stable antihypertensive treatment 2 weeks before start of study drug and throughout study duration.
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- Office blood pressure at screening meeting (visit 1), > 110/60mmHg and < 150/90mmHg. If BP > 150/90mmHg at visit 1, screening phase can be prolonged to 4 weeks#.
- Capable of giving signed informed consent.
- Women with childbearing potential* can only be included if a pregnancy test is negative at the screening visit. Moreover, women should be using contraception during the study.
- If the office blood pressure varies by approximately ±10 mmHg and is deemed acceptable by the investigator, the participant can be included.
- Women are considered of childbearing potential following menarche and until becoming post-menopausal (12 consecutive months without a menstrual period) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy (According to the Clinical Trial Facilitation Group, 2014-09-15).
Who cannot join
- Participants are excluded from the study is any of the following criteria apply:
- Treatment with amiloride alone or in combination or use of other types of K-sparing diuretics, MR antagonists (Spironolactone, eplerenone, finerenone)
- Ongoing cancer treatment
- Treatment with immunosuppressive therapy within 6 months prior to screening
- History of organ transplantation
- Evidence of current infection (CRP> 50 and temperature > 38◦C)
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- History of unstable or rapidly progressing renal disease (eGFR decreasing > 5ml/min/1.73m2 the last 2 months)
- Severe hepatic insufficiency classified as Child-Pugh C
- Patients on hypertension treatment who is not on stable antihypertensive treatment 2 weeks before start of study drug.
- Pregnancy or breastfeeding participants
- Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.
- Recent cardiovascular events in a patient:
- Less than two months post coronary artery revascularization.
- Acute stroke or TIA within two months prior to screening
- Acute coronary syndrome within two months prior to screening
- Patients who, in the judgement of the investigator may be at risk for dehydration.
- Known hypersensitivity to the study treatment (active substance or excipients)
- Known hypersensitivity to resonium
- Addison´s disease
- Gastric bypass operation
- Participation in other interventional trials
- Lactose intolerance
- Plasma potassium >4.9 mmol/l at screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Nephrology, Odense University Hospital
Odense, 5000
Claus Bistrup, MD, Professor, +45-23368077, claus.bistrup@rsyd.dk
Gitte Rye Hinrichs, MD, PhD, +4521695186, gitte.rye.hinrichs2@rsyd.dk
About this study
This is a randomized, placebo-controlled, double-blinded crossover trial testing the effects of amiloride in patients with chronic kidney disease (CKD) and proteinuria.
In CKD with proteinuria, there is aberrant filtration of serine proteases and complement precursors into the tubular lumen. The interaction of these factors leads to proinflammatory complement activation, which may promote inflammation, opsonization, and formation of the membrane-attack complex, causing cell injury.
Read more
With the aim of preserving kidney function, reducing cardiovascular morbidity, and delaying renal replacement therapy in CKD, this study tests whether amiloride (10 mg/day) protects the filtration barrier, lowers albuminuria, and mitigates kidney inflammation through urokinase inhibition, independent of blood pressure effects.
Participants are randomized to receive amiloride (10 mg/day) or placebo for one week, with a 2-3-week washout period in between. Blood and urine samples are collected before and after each treatment period. Additionally, ECG, body composition measurements, blood pressure, and body weight are monitored.
The primary outcome measures are urinary C3a, soluble C5-9 (sTCC/MAC), and kidney injury biomarkers KIM-1 and NGAL. Secondary endpoints include the urinary albumin/creatinine ratio, protein/creatinine ratio, and blood pressure.
Read the detailed description
Please refer to the protocol
- Conditions
- Chronic Kidney Disease(CKD), Proteinuria
- Being tested
- amiloride, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amilorideDrug
5mg twice daily for 7 days
PlaceboDrug
1 tablet twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Amiloride | Experimental | Amiloride 5mg twice daily for 7 days followed by 2-3 weeks of washout and then placebo twice daily for 7 days Receives: Drug: amiloride |
| Placebo | Placebo comparator | Placebo twice daily for 7 days followed by 2-3 weeks of washout and then Amilorid 5 mg twice daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine-C3a (ng/ml)
Urine-C3a is measured in spot urine samples and expressed as u-C3a/creatinine (µg/g) to account for the dilution factor.
Measured: Measured before (day one) and after (day 8) each treatment period
Urine C5-9-sTCC/MAC (U/ml)
Membrane Attack Complex (MAC) of the complement system, specifically targeting the C5 to C9 proteins. u-C5-9 is measured in spot urine samples and expressed as u-C5-9/creatinine U/µmol to account for the dilution factor.
Measured: Measured before (day one) and after (day 8) each treatment period
Kidney Injury Molecule-1 (KIM-1) pg/ml
KIM-1 is a protein that serves as a biomarker used particularly in the context of kidney injury
Measured: Measured before (day one) and after (day 8) each treatment period
Neutrophil Gelatinase-Associated Lipocalin (NGAL) (pg/mL)
NGAL is a protein associated with neutrophils used as a biomarker in the context of kidney injury.
Measured: Measured before and after each treatment period
Secondary outcomes (3)
Urine albumin/creatinin ratio (mg/g)
In spot urine samples, albumin and creatinin are measured
Measured: Measured before (day one) and after (day 8) each treatment period
Urine protein/creatinin ratio
In spot urine samples, albumin and creatinin are measured
Measured: Measured before (day one) and after (day 8) each treatment period
Home blood pressure (mmHg)
Home blood pressure are measured according to standard guidelines
Measured: Measured before (day one) and after (day 8) each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start10 Oct 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a randomized, double blinded, placebo controlled, crossover study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923709
- Sponsor's protocol ID
- EUCT: 2022-500692-31-00
- Other IDs
- 2022-500692-31-00
- Acronym
- A-CKD
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06923709
- Acronym / sponsor ID
- A-CKD / EUCT: 2022-500692-31-00
- Conditions
- Chronic Kidney Disease(CKD), Proteinuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo-controlled, double-blinded crossover trial testing the effects of amiloride in patients with chronic kidney disease (CKD) and proteinuria.
In CKD with proteinuria, there is aberrant filtration of serine proteases and complement precursors into the tubular lumen. The interaction of these factors leads to proinflammatory complement activation, which may promote inflammation, opsonization, and formation of the membrane-attack complex, causing cell injury.
With the aim of preserving kidney function, reducing cardiovascular morbidity, and delaying renal replacement therapy in CKD, this study tests whether amiloride (10 mg/day) protects the filtration barrier, lowers albuminuria, and mitigates kidney inflammation through urokinase inhibition, independent of blood pressure effects.
Participants are randomized to receive amiloride (10 mg/day) or placebo for one week, with a 2-3-week washout period in between. Blood and urine samples are collected before and after each treatment period. Additionally, ECG, body composition measurements, blood pressure, and body weight are monitored.
The primary outcome measures are urinary C3a, soluble C5-9 (sTCC/MAC), and kidney injury biomarkers KIM-1 and NGAL. Secondary endpoints include the urinary albumin/creatinine ratio, protein/creatinine ratio, and blood pressure.
Detailed description
Please refer to the protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study is a randomized, double blinded, placebo controlled, crossover study
| Arm | Type | Receives |
|---|---|---|
| Amiloride | Experimental | Drug: amilorideAmiloride 5mg twice daily for 7 days followed by 2-3 weeks of washout and then placebo twice daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice daily for 7 days followed by 2-3 weeks of washout and then Amilorid 5 mg twice daily for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants are eligible to be included in the study, only if all the following criteria apply:
- Participant must be 18 years of age including at the time of signing the informed consent.
- A clinical diagnosis of chronic kidney disease and:
- Participants must be on stable antihypertensive treatment 2 weeks before start of study drug and throughout study duration.
- Office blood pressure at screening meeting (visit 1), > 110/60mmHg and < 150/90mmHg. If BP > 150/90mmHg at visit 1, screening phase can be prolonged to 4 weeks#.
Key exclusion criteria (23 listed)
- Treatment with amiloride alone or in combination or use of other types of K-sparing diuretics, MR antagonists (Spironolactone, eplerenone, finerenone)
- Ongoing cancer treatment
- Treatment with immunosuppressive therapy within 6 months prior to screening
- History of organ transplantation
- Evidence of current infection (CRP> 50 and temperature > 38◦C)
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 |
|---|---|---|
| amiloride5mg twice daily for 7 days | Drug | Amiloride |
| Placebo1 tablet twice daily for 7 days | Drug | Placebo |
Primary outcome
Urine-C3a (ng/ml)
Time frame: Measured before (day one) and after (day 8) each treatment period
Urine-C3a is measured in spot urine samples and expressed as u-C3a/creatinine (µg/g) to account for the dilution factor.
Urine C5-9-sTCC/MAC (U/ml)
Time frame: Measured before (day one) and after (day 8) each treatment period
Membrane Attack Complex (MAC) of the complement system, specifically targeting the C5 to C9 proteins. u-C5-9 is measured in spot urine samples and expressed as u-C5-9/creatinine U/µmol to account for the dilution factor.
Kidney Injury Molecule-1 (KIM-1) pg/ml
Time frame: Measured before (day one) and after (day 8) each treatment period
KIM-1 is a protein that serves as a biomarker used particularly in the context of kidney injury
Neutrophil Gelatinase-Associated Lipocalin (NGAL) (pg/mL)
Time frame: Measured before and after each treatment period
NGAL is a protein associated with neutrophils used as a biomarker in the context of kidney injury.
3 secondary outcomes
Urine albumin/creatinin ratio (mg/g)
Time frame: Measured before (day one) and after (day 8) each treatment period
Urine protein/creatinin ratio
Time frame: Measured before (day one) and after (day 8) each treatment period
Home blood pressure (mmHg)
Time frame: Measured before (day one) and after (day 8) each treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amiloride in people with Chronic Kidney Disease(CKD) and Proteinuria, run by Odense University Hospital at 1 site in Denmark.
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 11 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 11 Apr 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 Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gitte Rye Hinrichs, MD, PhD (004521695186, gitte.rye.hinrichs2@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine-C3a (ng/ml) (time frame: Measured before (day one) and after (day 8) each treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2025.