2023-503941-69-00招募中2 期
Double-blind, placebo-controlled clinical trial to determine the effect of Patiromer on vascular function and its relationship with mineral metabolism parameters
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in indicators of arterial stiffness: pulse wave velocity and pulse pressure
研究概览
简要总结
To determine the effect of treatment with patiromer on vascular function and mineral metabolism in patients with CKD
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase II, doble-blind, unicenter, placebo-controlled
- 盲法
- Double (Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Changes in indicators of arterial stiffness: pulse wave velocity and pulse pressure
Changes in indicators of arterial stiffness: pulse wave velocity and pulse pressure
次要结局
- Peripheral and central blood pressure.
- Biomarcadores del metabolismo mineral (fosfato sérico, calcio y magnesio, FGF23, vitamina D y PTH)
- 24-hour urinary excretion of phosphate, calcium, sodium, and potassium
- Biomarkers of kidney damage: albumin/creatinine ratio, serum creatinine, eGFR
- Endothelial function
- Serum potassium concentration
研究者
José Carlos Garrido Gracia
Scientific
Fundacion Para La Investigacion Biomedica De Cordoba
研究点 (1)
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