Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease

Please refer to the protocol

Inclusion 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. 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).

Exclusion criteria

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 interventional trials
• Lactose intolerance
• Plasma potassium >4.9 mmol/l at screening