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

Vifor Pharma, Inc.0 个研究点目标入组 878 人开始时间: 2020年6月10日最近更新: 2021年11月15日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Vifor Pharma, Inc.
入组人数: 878

研究概览入排标准研究者记录与标识符相似试验

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. Current New York Heart Association (NYHA) Class II–IV HF
•4. Left ventricular ejection fraction =40%, measured by any echocardiographic, radionuclide, magnetic resonance imaging (MRI), angiographic, 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 beta-blocker (reason documented)
•6.eGFR =30 mL/min/1.73 m2 at Screening (based on a single local laboratory analysis of serum creatinine and 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 venipunctures, e.g., one in
•each arm or 2 separate venipunctures in the same arm) while receiving ACEi/ ARB/ ARNi/ and/or MRA
•Normokalemia at Screening (defined by 2 local serum K+ =4.0-=5.0 mEq/L each obtained from a separate venipuncture, e.g., one in each
•arm or two separate venipunctures in the same arm) but 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 leading to a subsequent and permanent 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. With hospitalization for HF or equivalent (e.g., emergency room or outpatient visit for worsening HF during which the subject received
•intravenous medications for the treatment of HF) within the last 12 months before Screening
•a) Without atrial fibrillation at Screening, brain natriuretic peptide (BNP*) level must be greater than 600 pcg/mL (71 pmol/L)
•b) With atrial fibrillation at Screening, BNP level must be greater than 300 pcg/mL (35 pmol/L) or NT-proBNP must be greater than 150 pcg/mL (18 pmol/L) or Nterminal pro b-type BNP (NT-proBNP) must be greater than 600 pcg/mL (71 pmol/L)
•Without hospitalization for HF or equivalent (e.g., emergency room or outpatient visit for worsening HF during which the subject received
•intravenous medications for the treatment of HF) within the last 12 months before Screening
•a) Without atrial fibrillation at Screening, BNP level must be greater than 300 pcg/mL (35 pmol/L) or NT-proBNP must be greater than 1,200
•pcg/mL (142 pmol/L)
•b) With atrial fibrillation at Screening, BNP level must be greater than 600 pcg/mL (71 pmol/L) or NT-proBNP must be greater than 2400
•pcg/mL (284 pmol/L)
•*For subjects treated with ARNi (sacubitril/valsartan) in the previous 4 weeks before Screening, only NT-proBNP values are to be considered.
•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 286
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 590

排除标准

•1. Current acute decompensated HF within 4 weeks before Screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 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 secondary mitral regurgitation due to left ventricular dilatation)
•4. Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting 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 before Screening
•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. Note: This exclusion criterion is included in the new Inclusion Criterion 9
•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, prostate
•cancer with Gleason score <7, 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 4 weeks 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. Note: This exclusion criterion is modified and partially incorporated in Exclusion Criterion 18
•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, or patiromer
•19. An employee, spouse, or family member of the Sponsor (Vifor Pharma), investigational site or the Contract Research Organization

研究者

发起方

Vifor Pharma, Inc.

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