Can patiromer allow for intensified renin-angiotensin-aldosterone system blockade with losartan and spironolactone leading to decreased albuminuria in patients with chronic kidney disease, albuminuria and hyperkalaemia? An open-label randomised controlled trial: MorphCKD
| Autor: | Frederik Husum Mårup, Christian Daugaard Peters, Jeppe Hagstrup Christensen, Henrik Birn |
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| Rok vydání: | 2022 |
| Předmět: |
Male
Hyperkalemia/drug therapy Renal Insufficiency Chronic/complications Polymers nephrology Angiotensin Receptor Antagonists/pharmacology Angiotensin-Converting Enzyme Inhibitors Spironolactone Losartan Renin-Angiotensin System Angiotensin Receptor Antagonists chronic renal failure Losartan/pharmacology Mineralocorticoid Receptor Antagonists/adverse effects Albuminuria Humans Renal Insufficiency Chronic Mineralocorticoid Receptor Antagonists General Medicine adult nephrology Spironolactone/therapeutic use diabetic nephropathy & vascular disease Albuminuria/complications Angiotensin-Converting Enzyme Inhibitors/adverse effects Potassium Quality of Life Hyperkalemia Female |
| Zdroj: | Mårup, F H, Peters, C D, Christensen, J H & Birn, H 2022, ' Can patiromer allow for intensified renin-angiotensin-aldosterone system blockade with losartan and spironolactone leading to decreased albuminuria in patients with chronic kidney disease, albuminuria and hyperkalaemia? An open-label randomised controlled trial: MorphCKD ', BMJ Open, vol. 12, no. 2, e057503 . https://doi.org/10.1136/bmjopen-2021-057503 |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2021-057503 |
| Popis: | IntroductionChronic kidney disease (CKD) is associated with significantly increased morbidity and mortality. No specific treatment of the underlying condition is available for the majority of patients, but ACE-inhibitors (ACE-I) and angiotensin II-receptor blockers (ARB) slows progression in albuminuric CKD. Adding a mineralocorticoid receptor-antagonist (MRA) like spironolactone has an additive effect. However, renin–angiotensin–aldosterone system (RAAS)-blockade increases the risk of hyperkalaemia which is exacerbated by the presence of CKD. Thus, hyperkalaemia may prevent optimal use of RAAS-blockade in some patients.This project hypothesises that adding a potassium binder (patiromer) allows for improved RAAS-blockade including the use of MRA, thereby reducing albuminuria in patients with albuminuric CKD where full treatment is limited by hyperkalaemia.If successful, the study may lead to improved treatment of this subgroup of patients with CKD. Furthermore, the study will examine the feasibility of potassium binders in patients with CKD.Methods and analysisAn open-label, randomised controlled trial including 140 patients with estimated glomerular filtration rate (eGFR) 25–60 mL/min/1.73 m2, a urinary albumin/creatinine ratio (UACR) >500 mg/g (or 200 mg/g if diabetes mellitus) and a current or two previous plasma-potassium >4.5 mmol/L. Patients who develop hyperkaliaemia >5.5 mmol/L during a run-in phase, in which RAAS-blockade is intesified with the possible addition of spironolactone, are randomised to 12-month treatment with maximal tolerated ACE-I/ARB and spironolactone with or without patiromer.The primary endpoint is the difference in UACR measured at randomisation and 12 months compared between the two groups. Secondary endpoints include CKD progression, episodes of hyperkalaemia, blood pressure, eGFR, markers of cardiovascular disease, diet and quality of life.Ethics and disseminationThis study is approved by The Central Denmark Region Committees on Health Research Ethics (REFNO 1-10-72-110-20) and is registered in the EudraCT database (REFNO 2020-001595-15). Results will be presented in peer-reviewed journals, at meetings and at international conferences. |
| Databáze: | OpenAIRE |
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