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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CLP
placebo
Sponsored by
Sorbent Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orange Country Research CenterRecruiting
  • Recruiting
  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CLP

Placebo

Arm Description

CLP BID

BID powder

Outcomes

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
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 to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death

Full Information

First Posted
November 26, 2012
Last Updated
March 3, 2014
Sponsor
Sorbent Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01736735
Brief Title
Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
Acronym
STEPWISE
Official Title
A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorbent Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLP
Arm Type
Experimental
Arm Description
CLP BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
BID powder
Intervention Type
Drug
Intervention Name(s)
CLP
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change in 6-Minute Walk Test distance from baseline to Week 8.
Time Frame
Baseline, Week 8
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jade Brennan
Phone
919-491-5721
Email
jadebrennan@momentum-research.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Chang
Email
jchang@sorbent.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Dittrich, MD
Organizational Affiliation
Sorbent Therapeutics, Study Sponsor
Official's Role
Study Chair
Facility Information:
Facility Name
Orange Country Research Center
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Neutel, MD
City
Buenos Aires
Country
Argentina
Individual Site Status
Recruiting
City
Ashkelon
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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