Double-blind, placebo-controlled clinical trial to determine the effect of Patiromer on vascular function and its relationship with mineral metabolism parameters - PATIvasc

Fundacion Para La Investigacion Biomedica De Cordoba0 个研究点目标入组 40 人开始时间: 2023年4月28日最近更新: 2024年7月22日

适应症

试验速览

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•18 years and older of both sexes., Chronic kidney disease, defined by an eGFR 15-60 ml/min/1.73m2 estimated using the CKD-EPI equation, Potassium levels between 5 and 6 mEq/L in at least 2 of 4 previous blood test results and potassium level between 5 and 6 mEq/L at screening visit, Must be on ACEI or ARB or aldosterone antagonist therapy for at least one month prior to screening at the highest tolerated dose., Patient capable of understanding the study procedures and who gives their informed consent to participate

•Episodes of known clinically significant cardiac arrest or ventricular arrhythmias, Current use of polymer-based drugs such as cholestyramine, coveselam, or sodium polystyrene sulfonate, History of gastroparesis or intestinal obstruction, swallowing disorders, or major gastrointestinal surgery, History of stroke, myocardial infarction, decompensated heart failure, percutaneous coronary intervention or coronary bypass in the last 3 months, Patients with severe physical or mental disabilities that, in the opinion of the investigator, could interfere with the fulfillment of the study requirements, Presence of any condition that, in the opinion of the investigator, puts the patient at risk or could potentially impair the quality of the data, Drug or alcohol addiction that, in the investigator's opinion, could interfere with compliance with study requirements, Inability or unwillingness of the individual or legal guardian or representative to give written informed consent, Previous kidney or heart transplant, Severe hypomagnesemia (<1.4 mg/dl), Active cancer, excluding non-melanocytic skin cancer, considered already cured, Treatment with anticancer drugs or immunotherapy, Pregnant or lactating women, History of drug or alcohol abuse, Continuous use of potassium supplements in the month prior to screening, Current use of calcium-containing or calcium-free phosphate chelators

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