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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014