Beneficial Effect of Amiloride on Progression of Chronic Kidney Disease

Prior treatment

• Treatment with amiloride alone or in combination or use of other types of K-sparing diuretics, MR antagonists (Spironolactone, eplerenone, finerenone)
• Treatment with immunosuppressive therapy within 6 months prior to screening
• Patients on hypertension treatment who is not on stable antihypertensive treatment 2 weeks before start of study drug.
• 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

Other illness

• Ongoing cancer treatment
• History of organ transplantation
• Evidence of current infection (CRP\> 50 and temperature \> 38◦C)
• Severe hepatic insufficiency classified as Child-Pugh C
• Congestive heart failure NYHA class IV, unstable or acute congestive heart failure.
• Known hypersensitivity to the study treatment (active substance or excipients)
• Known hypersensitivity to resonium
• Addison´s disease

Lab values

• History of unstable or rapidly progressing renal disease (eGFR decreasing \> 5ml/min/1.73m2 the last 2 months)
• Plasma potassium \>4.9 mmol/l at screening

Other

• Participants are excluded from the study is any of the following criteria apply:
• Pregnancy or breastfeeding participants
• Patients who, in the judgement of the investigator may be at risk for dehydration.
• Gastric bypass operation
• Participation in other interventional trials
• Lactose intolerance

• 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).