Beneficial effects of Amiloride on progression of Chronic Kidney Disease: A-CKA

Phase 1

Active, not recruiting

• Conditions: Chronic kidney disease (CKD); MedDRA version: 21.1Level: PTClassification code: 10064848Term: Chronic kidney disease Class: 100000004857; Therapeutic area: Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

• Registration Number: CTIS2022-500692-31-00
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Participant must be 18 years of age including at the time of signing the informed consent, A clinical diagnosis of chronic kidney disease and: oeGFR = 25 but < 60mL/min/1.73m2 at screening oUACR 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) > 110/65mmHg 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.

Exclusion Criteria

Treatment with amiloride alone or use of other types of K-sparing diuretics will be avoided, MR antagonists (Spironolactone, eplerenone, finerenone), Lactose intolerance, 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, Treatment with immunosuppressive therapy within 6 months prior to screening, History of organ transplantation, Participation in other interventional trials, Plasma potassium > 4.9mmol/L, 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., Ongoing cancer treatment, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified