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

Heart Failure Clinical Trial

— STEPWISE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01736735
• Other study ID #: CTST-24
• Status: Recruiting
• Phase: Phase 2
• First received: November 26, 2012
• Last updated: March 3, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: Sorbent Therapeutics
• Contact: Jade Brennan
• Phone: 919-491-5721
• Email: jadebrennan[@]momentum-research.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• CLP

• placebo

Locations

Country	Name	City	State
United States	Orange Country Research Center	Tustin	California

Sponsors (1)

Lead Sponsor	Collaborator
Sorbent Therapeutics

Countries where clinical trial is conducted

United States,  Argentina,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Week 8	No
Secondary	Change in 6-Minute Walk Test distance from baseline to Week 8.		Baseline, Week 8	No
Secondary	Time to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death		8 weeks	No