Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects (STEPWISE)

Sorbent Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Heart Failure

Treatments: Drug: CLP; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01736735

CTST-24

Details and patient eligibility

About

This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.

Enrollment: 270 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Selected Inclusion Criteria:

• Age 21 years or older at randomization

• Heart failure with at least one of the following signs of current fluid overload:

  1. Peripheral (or sacral) edema >1+ or ascites during screening or on day of randomization
  2. Pulmonary congestion as determined by chest X-ray during the screening period

• Ambulatory and able to perform the 6-minute walk test

Selected Exclusion Criteria:

• Participation in another clinical trial of an investigational or marketed drug within 30 days or 5 half-lives (whichever is longer) preceding screening
• Any hospitalization or unscheduled outpatient decongestion therapy using IV diuretics, ultrafiltration, or paracentesis within 8 weeks prior to or during screening
• Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 2 months prior to or during screening or anticipated need during study participation
• Heart transplant recipient, or anticipated need for transplant or LVAD during study participation
• Any of the following events having occurred within 8 weeks prior to or during screening: myocardial infarction, transient ischemic attack, stroke, or acute coronary syndrome as judged by the Investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups, including a placebo group

CLP

Experimental group

Description:

CLP BID

Treatment:

Drug: CLP

Placebo

Placebo Comparator group

Description:

BID powder

Treatment:

Drug: placebo