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

This study is currently recruiting participants.
Verified March 2014 by Sorbent Therapeutics
Sponsor:
Information provided by (Responsible Party):
Sorbent Therapeutics
ClinicalTrials.gov Identifier:
NCT01736735
First received: November 26, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Heart Failure
Drug: CLP
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects

Resource links provided by NLM:


Further study details as provided by Sorbent Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Change in 6-Minute Walk Test distance from baseline to Week 8. [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
  • Time to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CLP
CLP BID
Drug: CLP
Placebo Comparator: Placebo
BID powder
Drug: placebo

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736735

Contacts
Contact: Jade Brennan 919-491-5721 jadebrennan@momentum-research.com
Contact: Jean Chang jchang@sorbent.com

Locations
United States, California
Orange Country Research Center Recruiting
Tustin, California, United States, 92780
Principal Investigator: Joel Neutel, MD         
Argentina
Recruiting
Buenos Aires, Argentina
Israel
Recruiting
Ashkelon, Israel
Sponsors and Collaborators
Sorbent Therapeutics
Investigators
Study Chair: Howard Dittrich, MD Sorbent Therapeutics, Study Sponsor
  More Information

No publications provided

Responsible Party: Sorbent Therapeutics
ClinicalTrials.gov Identifier: NCT01736735     History of Changes
Other Study ID Numbers: CTST-24
Study First Received: November 26, 2012
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014