Effects of Amiloride on Chronic Kidney Disease Progression

Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease

This study is testing if the medication amiloride can help people with chronic kidney disease by protecting their kidneys and reducing protein in their urine without changing their blood pressure.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Odense University Hospital (Academic / other)
• Locations: 1 site (Odense)
• Trial ID: NCT06923709 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled, double-blinded crossover trial investigates the impact of amiloride on patients with chronic kidney disease (CKD) and proteinuria. The study aims to determine if amiloride can protect the kidney filtration barrier, reduce albuminuria, and decrease kidney inflammation without affecting blood pressure. Participants will receive either amiloride or a placebo for one week, followed by a washout period before switching treatments. Blood and urine samples will be collected to assess the drug's efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic kidney disease, an eGFR between 25 and 60 mL/min/1.73m2, and significant proteinuria.

Not a fit: Patients with an eGFR below 25 mL/min/1.73m2 or those not on stable antihypertensive treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved kidney function and reduced cardiovascular risks for patients with chronic kidney disease.

How similar studies have performed: Other studies have explored the effects of similar interventions on kidney disease, but this specific approach with amiloride is relatively novel.

Eligibility criteria

Inclusion criteria

Participants are eligible to be included in the study, only if all the following criteria apply:

1. Participant must be 18 years of age including at the time of signing the informed consent.
2. A clinical diagnosis of chronic kidney disease and:

   1. eGFR ≥ 25 mL/min/1.73m2 and \< 60mL/ min/1.73m2 at screening
   2. UACR of ≥ 300mg/g at screening
3. Participants must be on stable antihypertensive treatment 2 weeks before start of study drug and throughout study duration.
4. 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#.
5. Capable of giving signed informed consent.
6. 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).

Exclusion criteria

Participants are excluded from the study is any of the following criteria apply:

1. Treatment with amiloride alone or in combination or use of other types of K-sparing diuretics, MR antagonists (Spironolactone, eplerenone, finerenone)
2. Ongoing cancer treatment
3. Treatment with immunosuppressive therapy within 6 months prior to screening
4. History of organ transplantation
5. Evidence of current infection (CRP\> 50 and temperature \> 38◦C)
6. History of unstable or rapidly progressing renal disease (eGFR decreasing \> 5ml/min/1.73m2 the last 2 months)
7. Severe hepatic insufficiency classified as Child-Pugh C
8. Patients on hypertension treatment who is not on stable antihypertensive treatment 2 weeks before start of study drug.
9. Pregnancy or breastfeeding participants
10. Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.
11. Recent cardiovascular events in a patient:

    1. Less than two months post coronary artery revascularization.
    2. Acute stroke or TIA within two months prior to screening
    3. Acute coronary syndrome within two months prior to screening
12. Patients who, in the judgement of the investigator may be at risk for dehydration.
13. Known hypersensitivity to the study treatment (active substance or excipients)
14. Known hypersensitivity to resonium
15. Addison´s disease
16. Gastric bypass operation
17. Participation in other interventional trials
18. Lactose intolerance
19. Plasma potassium \>4.9 mmol/l at screening

Where this trial is running

Odense

• Department of Nephrology, Odense University Hospital — Odense, Denmark (Recruiting)

Study contacts

• Study coordinator: Gitte Rye Hinrichs, MD, PhD

Conditions Chronic Kidney Disease; Proteinuria