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

Phase 2

• Conditions: Heart Failure
• Interventions: Drug: CLP; Drug: placebo

• Registration Number: NCT01736735
• Lead Sponsor: Sorbent Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-29
• Study Start: 2013-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-03
• Last Update Posted: 2014-03-05
• Primary Completion: 2014-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLP	CLP	CLP BID
Placebo	placebo	BID powder

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Orange Country Research Center; 🇺🇸 Tustin, California, United States