EUCTR2018-005030-38-IT进行中（未招募）1 期
A Multicenter, Double-blind, Placebo controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin Angiotensin Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND) - DIAMOND
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Relypsa Inc
- 入组人数
- 878
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject provides written informed consent prior to study participation
- •2. Age at least 18 years or greater
- •3. History of New York Heart Association (NYHA) Class II–IV HF
- •4. Left ventricular ejection fraction <40%, measured by any echocardiographic, radionuclide, or computerized tomography method in the last 12 months
- •without subsequent measured ejection fraction =40% during this interval)
- •5. Receiving any dose of a beta blocker (BB) for the treatment of HF or unable to tolerate BB (reason documented)
- •6.Estimated glomerular filtration rate (eGFR) =30 mL/min/1.73 m2 at Screening (based on a single local laboratory calculation using the Chronic Kidney
- •Disease Epidemiology Collaboration (CKD-EPI) equation; see Section 9.2 of the protocol)
- •7. Hyperkalemia at Screening (defined by 2 local serum K+ values of >5.0 mEq/L each obtained from a separate venipuncture, e.g., one in each arm)
- •while receiving ACEi, ARB, ARNi, and/or MRA,
- •Normokalemia at Screening (serum K+ 4.0–5.0 mEq/L) with a history of hyperkalemia documented by a usual care serum K+ measurement >5.0
- •mEq/L while on RAASi treatment in the 12 months prior to Screening with a subsequent dose decrease or discontinuation of one or more
- •RAASi medications
- •8. Females of child-bearing potential must be non-lactating, must have a negative pregnancy test at Screening, and must agree to continue using contraception (see Section 9.8 of the protocol) throughout the study and for 4 weeks after study completion
- •9. Hospitalization for HF or equivalent (e.g., urgent emergency room or outpatient visit for worsening HF during which the patient received intravenous medications for the treatment of HF) within last 12 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1194
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1194
排除标准
- •1.Current acute decompensated HF. Subjects with a discharge from a hospitalization for acute decompensation of HF at least 4 weeks before
- •Screening may be included
- •2. Symptomatic hypotension or systolic blood pressure <90 mmHg
- •3. Significant primary aortic or mitral valvular heart disease (except mitral regurgitation due to left ventricular dilatation)
- •4. Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant list) during the study period
- •5. Diagnosis of peripartum or chemotherapy-induced cardiomyopathy or acute myocarditis in the previous 12 months
- •6. Implantation of a cardiac resynchronization therapy device in the previous 4 weeks
- •7. Restrictive, constrictive, hypertrophic, or obstructive cardiomyopathy
- •8. Untreated ventricular arrhythmia with syncope in the previous 4 weeks
- •9. History of, or current diagnosis of, a severe swallowing disorder, moderate-to-severe gastroparesis, or major gastrointestinal (GI)
- •surgery (e.g., bariatric surgery or large bowel resection)
- •10. A major CV event within 4 weeks prior to Screening, including acute myocardial infarction, stroke (or transient ischemic attack), a lifethreatening
- •atrial or ventricular arrhythmia, or resuscitated cardiac arrest.
- •11. Brain natriuretic peptide (BNP) <125 pcg/mL or N-terminal pro btype brain natriuretic peptide (NT-proBNP) of <500 pcg/mL
- •12. Liver enzymes (alanine aminotransferase, aspartate aminotransferase) >5 times upper limit of normal at Screening based on
- •the local laboratory
- •13. Diagnosis or treatment of a malignancy in the past 2 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix, or a
- •condition highly likely to transform into a malignancy during the study
- •14. Presence of any condition (e.g., drug/alcohol abuse; acute illness), in the opinion of the Investigator, that places the subject at undue risk,
- •or prevents complete participation in the trial procedures, or potentially jeopardizes the quality of the study data
- •15. Use of any investigational product for an unapproved indication within 1 month prior to Screening or currently enrolled in any other type
- •of medical research judged not to be scientifically or medically compatible with this study
- •16. Known hypersensitivity to patiromer (RLY5016) or its components
- •17. Prior use of commercial patiromer or previous participation in a study assessing patiromer
- •18. Subjects currently being treated with or having taken any one of the following medications in the 7 days prior to Screening: sodium or
- •calcium polystyrene sulfonate or sodium zirconium cyclosilicate
- •19. An employee of Relypsa, Vifor Pharma, investigational site or the contract research organization (CRO)
研究者
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