A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects

Sorbent Therapeutics1 site in 1 country270 target enrollmentJanuary 2013

ConditionsHeart Failure

InterventionsCLP placebo

DrugsCLP placebo

Overview

Phase: Phase 2
Intervention: CLP
Conditions: Heart Failure
Sponsor: Sorbent Therapeutics
Enrollment: 270
Locations: 1
Primary Endpoint: Composite endpoint comprised of: 6-Minute Walk Test, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart/renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart/renal failure or death
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

June 2014

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sorbent Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 21 years or older at randomization
•Heart failure with at least one of the following signs of current fluid overload:
•Peripheral (or sacral) edema \>1+ or ascites during screening or on day of randomization
•Pulmonary congestion as determined by chest X-ray during the screening period
•Ambulatory and able to perform the 6-minute walk test

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

Arms & Interventions

CLP

CLP BID

Intervention: CLP

Placebo

BID powder

Intervention: placebo

Outcomes

Primary Outcomes

Composite endpoint comprised of: 6-Minute Walk Test, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart/renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart/renal failure or death

Time Frame: Baseline, Week 8

Composite endpoint for the change from baseline to 8 weeks comprised of the following: 6-Minute Walk Test (6 MWT), Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death.

Secondary Outcomes

Change in 6-Minute Walk Test distance from baseline to Week 8.(Baseline, Week 8)
Time to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death(8 weeks)