A placebo controlled Study of Patiromer for the Management of high potassium serum levels in Subjects Receiving a certain group of medications called Renin-Angiotensin-Aldosterone System Inhibitor for treatment of Heart failure.
- Conditions
- Management of hyperkalemia due to renin-angiotension-aldosterone system medications in patients treated for heart failure.MedDRA version: 21.0Level: PTClassification code 10005725Term: Blood potassium increasedSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Not possible to specify
- Registration Number
- EUCTR2018-005030-38-DE
- Lead Sponsor
- Vifor Pharma, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 878
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 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 venipuncture, e.g., one in each arm or two separate venipunctures in the same arm) while receiving ACEi/ ARB / ARNi, and/or MRA
OR
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) 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 150 pcg/mL (18 pmol/L) or Nterminal pro b-type BNP (NT-proBNP) 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 1,200 pcg/mL (142 pmol/L)
OR
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 268
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 590
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 life-threatening 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
(CRO)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method