2025-521378-33-00招募中3 期
Impact of Patiromer treatment on dietary Potassium intake restriction and health-related quality of life and nutrition in patients on Chronic Dialysis Therapy: a Double-Blind, Prospective, Randomized, Placebo-Controlled, Pilot Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Proportion of participants with low-potassium diet withdrawal and/or down-titration at completion of the treatment period compared to diet at inclusion
研究概览
简要总结
To assess whether treatment with the oral potassium binder patiromer as compared to placebo allows withdrawal or down-titration of potassium dietary restriction considered as a dichotomous variable (YES/NO) without increasing the risk of hyperkalemia (serum potassium >5.5 mEq/L) in chronic dialysis patients with pre-dialysis serum potassium 4 to 5.5 mEq/L ) achieved and maintained by dietary restriction of potassium reach aliments
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
- 是
入选标准
- •More than 18-year-old
- •Chronic and stable dialysis therapy with three weekly dialysis sessions for at least three months because of ESKD
- •Pre-dialysis (in the long interdialytic period) serum potassium 4 to 5.5 mEq/L confirmed in two consecutive weeks, without any clinical signs or symptoms of hyperkalemia
- •Stable therapy (since at least 3 months) with RAS inhibitors or MRAs. No treatment with potassium sparing diuretics On standardized and stable (moderately or strictly restricted) low-potassium diet
- •Compliance with recommended diet
- •Written informed consent
排除标准
- •Hyperkalemia (pre-dialysis potassium >5.5 mEq/L during the long interdialytic period)
- •Previous history of cardiac arrhythmias potentially related to hypokalemia
- •Known hypersensitivity to the active ingredient or any of the excipients of the study drug
- •Inability to fully understand the potential risks and benefits related to study participation
- •Concomitance of clinical conditions that could jeopardize the completion of the treatment period and/or confound data interpretation including: • Cancer (except non-metastatic cutaneous cancers) • Active systemic autoimmune diseases • Concomitant treatment with steroids or any other immunosuppressive agent • Severe/unstable heart failure requiring hospitalization or changes in pharmacological therapy or supplementary dialysis sessions over the last three months • Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications) • Known to be positive for human immunodeficiency virus • Drug or alcohol abuse
- •Pregnancy, lactation, or intention to become pregnant before or during the study period, or within 90 days of the last dose of study treatment
- •Intention to donate ova or sperm over the same period
- •Childbearing potential without highly effective contraception methods according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (https://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2020_09_HMA_CTFG_Contraception_guidance_Version_1.1_updated.pdf)
- •Involvement in the study planning and/or conduct
- •Participation in another clinical study with an investigational product during the last month
- •Hypomagnesemia (serum magnesium <1.7 mg/dL)
- •Hypercalcemia (serum calcium >10.5mg/dl)
- •Ongoing treatment with potassium binding medications including Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or Sodium zirconium cyclosilate (Lokelma®, Astra Zeneca S.p.A.)
- •Ongoing treatment with potassium-sparing diuretics
- •Pre-dialysis potassium <4.0 mEq/L during the long interdialytic period
- •One or two weekly dialysis session
- •Poor compliance to prescribed potassium-restricted diet
- •History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders
结局指标
主要结局
Proportion of participants with low-potassium diet withdrawal and/or down-titration at completion of the treatment period compared to diet at inclusion
Proportion of participants with low-potassium diet withdrawal and/or down-titration at completion of the treatment period compared to diet at inclusion
次要结局
- Proportion of participants with low potassium diet withdrawal at completion of the treatment period, considered as a single endpoint
- Reduction in dietary restriction considered as a continuous variable as assessed by a dietary score (to be defined): 0 = No restriction; 1 = Moderate restriction; 2 = Strict restriction
- Changes in pre-dialysis serum potassium level considered as a continuous variable
- Reduced need for rescue therapy with potassium binding resins such as Sodium polystyrene sulfonate (SPS, Kayexalate®, Sanofi-Aventis S.p.A) or supplementary dialysis sessions to treat intercurrent hyperkalemia
- Introduction or optimization of RAS inhibitor therapy to control arterial blood pressure or heart failure and/or prevent cardiovascular events without increasing the risk of hyperkalemia
- Proportion of patients with cardiac arrhythmias or other symptoms (muscle weakness, fatigue, hand of feet numbness or tingling, vomiting, flaccid paralysis and others) potentially related to hyperkalemia
- Proportion of patients with hypokalemia (serum potassium <3.5 mEq/L) and/or of cardiac arrhythmias potentially related to hypokalemia
- Participant’s quality of life change from baseline at the end of the intervention, measured using the Italian translation of the Kidney Disease Quality of Life Instrument (KDQOL) Version 1.31 and the standard SF-36 quality of life questionnaire Italian Version 1.6
研究者
Ufficio Attività Regolatorie
Scientific
Istituto Di Ricerche Farmacologiche Mario Negri
研究点 (3)
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