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Evaluation of Patiromer in Heart Failure Patients (PEARL-HF)

2021年5月10日 更新者：Relypsa, Inc.

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Study to Evaluate the Effects of Patiromer in Heart Failure Patients

The purpose of this study was to assess the effects of patiromer on serum potassium participants with heart failure. This study also assessed the safety and tolerability of patiromer in participants with heart failure.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This was a double-blind, randomized, placebo-controlled, parallel-group, multiple-dose study in congestive heart failure participants. Depending on the outcome from the initial cohort of 100 participants (Part 1), a second cohort of 170 participants could have been enrolled (Part 2). Based on the results of Part 1 of the study, Part 2 was not conducted.

Participants were randomly assigned to and received patiromer (30 g/day) or placebo for up to 28 days. All participants also received spironolactone; the initial spironolactone dose was 25 mg daily and was increased to 50 mg daily for participants who had a serum potassium ≤ 5.1 mEq/L on treatment Day 14. Study visits occurred on treatment Days 3, 7, 14, 17, 21 and 28. A safety follow-up contact was made 7 days after administration of last dose of study drug.

研究类型

介入性

注册 (实际的)

120

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 乌克兰
      • Dnipropetrovsk、乌克兰、49023
        • Investigator Site 507
      • Kharkiv、乌克兰、61018
        • Investigator Site 502
      • Kharkiv、乌克兰、61176
        • Investigator Site 509
      • Kiev、乌克兰、03680
        • Investigator Site 504
      • Kiev、乌克兰、03680
        • Investigator Site 506
      • Kiev、乌克兰、04114
        • Investigator Site 501
  • 乔治亚州
      • Tbilisi、乔治亚州、0102
        • Investigator Site 605
      • Tbilisi、乔治亚州、0159
        • Investigator Site 602
      • Tbilisi、乔治亚州、0164
        • Investigator Site 604
      • Tbilisi、乔治亚州、0179
        • Investigator Site 603
  • 俄罗斯联邦
      • Barnaul、俄罗斯联邦、656099
        • Investigator Site 409
      • Kemerovo、俄罗斯联邦、650002
        • Investigator Site 407
      • Moscow、俄罗斯联邦、111020
        • Investigator Site 406
      • Moscow、俄罗斯联邦、111539
        • Investigator Site 402
      • Moscow、俄罗斯联邦、129301
        • Investigator Site 403
      • St Petersburg、俄罗斯联邦、197341
        • Investigator Site 404
      • St Petersburg、俄罗斯联邦、198205
        • Investigator Site 412
      • St Petersburg、俄罗斯联邦、199106
        • Investigator Site 405
  • 德国
      • Gottingen、德国、37075
        • Investigator site 201
      • Heidelberg、德国、69120
        • Investigator site 202
  • 捷克语
      • Brno、捷克语、62500
        • Investigator site 102
      • Prague、捷克语、12008
        • Investigator site 104
      • Prague、捷克语、14021
        • Investigator site 103
  • 波兰
      • Warsaw、波兰、02637
        • Investigator Site 305
  • 美国
    • Florida
      • Miami、Florida、美国、33176
        • Investigator Site 029
      • Port Charlotte、Florida、美国、33952
        • Investigator Site 031
    • Illinois
      • Peoria、Illinois、美国、61606
        • Investigator Site 009
    • Minnesota
      • Minneapolis、Minnesota、美国、55417
        • Investigator Site 018
    • New York
      • Buffalo、New York、美国、14215
        • Investigator Site 020
      • Northport、New York、美国、11768
        • Investigator Site 005
    • Ohio
      • Columbus、Ohio、美国、43210
        • Investigator Site 022
    • Texas
      • Dallas、Texas、美国、75216
        • Investigator Site 001
    • Utah
      • Salt Lake City、Utah、美国、84124
        • Investigator Site 019

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participants with chronic heart failure clinically indicated to receive spironolactone therapy, aged 18 years or older with serum potassium level of 4.3 - 5.1 mEq/L at screening and baseline, AND (1) chronic kidney disease (GFR < 60 mL/min) OR (2) documented history of hyperkalemia within the last 6 months
  • Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, and must have used a highly effective form of contraception for at least 3 months before study drug administration, during the study, and for one month after study completion
  • Male participants and/or their female partners of child-bearing potential must use a highly effective form of contraception during the study and for 3 months after study completion
  • Must sign informed consent document

Exclusion Criteria:

  • History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
  • Uncorrected hemodynamically significant primary valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia
  • Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 3 months prior to baseline or anticipated need during study participation
  • Heart transplant recipient, or anticipated need for transplant during study participation
  • Any of the following events having occurred within 3 months prior to baseline: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, transient ischemic attack or stroke
  • Current dialysis participant, or anticipated need for dialysis during study participation
  • Prior kidney transplant, or anticipated need for transplant during study participation
  • Metastatic, late-stage or end-stage cancer with < 12 months life expectancy
  • History of alcoholism or drug/chemical abuse within 1 year
  • QTcB interval > 500 msec (Bazett's correction formula)
  • Sustained systolic blood pressure > 170 or < 90 mmHg
  • Liver enzymes (ALT, AST) > 3 times upper limit of normal
  • Use of oral cardiac medications (including loop and thiazide diuretics) that have not been stable for at least 21 days prior to baseline and are not anticipated to remain stable during study participation
  • Use of any IV cardiac medications within 21 days prior to baseline, or their anticipated need during study participation.
  • Current use of polymer-based drugs (e.g. Renagel, Kayexalate, Welchol, Colestid), other phosphate binders or potassium binders, calcium supplements, antacids (eg TUMS, Maalox), or their anticipated need during study participation
  • Use of aldosterone antagonist in the last 30 days prior to baseline, unless was discontinued due to hyperkalemia
  • Use of potassium sparing medication and/or potassium supplements in the last 30 days prior to baseline
  • Use of any investigational medication, 30 days or 5 half-lives whichever is longer, prior to baseline
  • Participants who have taken investigational product in this study, or a previous patiromer study
  • Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol
  • In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, serious intercurrent illness, or extenuating circumstance occurring or persisting, within 30 days prior to baseline, that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：安慰剂
安慰剂
有源比较器：patiromer
药品：帕蒂默
活性研究药物
其他名称：
  • RLY5016
  • 维尔塔萨

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Change From Baseline in Serum Potassium to the End of the 28-day Treatment Period.
大体时间：Baseline and Day 28
Baseline and Day 28

次要结果测量

结果测量
措施说明
大体时间
Proportion of Participants With a Serum Potassium Level During the 28-day Treatment Period That Was > 5.5 mEq/L.
大体时间：28 Days
Analysis based on central laboratory data.
28 Days
Proportion of Participants Discontinuing the Study Due to Serum Potassium Elevation (Serum K+ > 5.5 mEq/L).
大体时间：28 Days
Analysis based on local laboratory data.
28 Days
Proportion of Participants Whose Spironolactone Dose Was Increased.
大体时间：28 Days
28 Days
Proportion of Participants With an Increase in Serum Potassium Level From Baseline to the End of the 28-day Treatment Period That Was ≥ 0.5 mEq/L
大体时间：Baseline and Day 28
Baseline and Day 28
Time to First Elevated Serum K+ > 5.5 mEq/L.
大体时间：28 Days
28 Days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Relypsa, Inc.

合作者

Medpace, Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年4月1日

初级完成 (实际的)

2009年11月1日

研究完成 (实际的)

2009年12月1日

研究注册日期

首次提交

2009年3月23日

首先提交符合 QC 标准的

2009年3月24日

首次发布 (估计)

2009年3月25日

研究记录更新

最后更新发布 (实际的)

2021年6月2日

上次提交的符合 QC 标准的更新

2021年5月10日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • RLY5016-202

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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