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New treatment option for Chronic Kidney Disease(CKD)
Official title Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease
ClinicalTrials.gov ID: NCT06923709
What this study is testing
What is amiloride?
amiloride is an investigational medicine, given as an once-daily, being studied as a potential treatment for chronic kidney disease(ckd).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility criteria
- 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.
- Office blood pressure at screening meeting (visit 1), \> 110/60mmHg and \ 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...
- 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)
- 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 treatment trials
- Lactose intolerance
- Plasma potassium \>4.9 mmol/l at screening
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.