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

NCT01736735 | Unknown Phase 2 DMC

• 1 other identifier: CTST-24
• Study Type: interventional
• Target: 270
• Locations: 3 countries
• Sites: 3

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

CLP

EXPERIMENTAL

CLP BID

Drug: CLP

Placebo

PLACEBO COMPARATOR

BID powder

Drug: placebo

Interventions

CLP DRUG

CLP

placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorbent Therapeutics: lead

Study Sites (3)

Orange Country Research Center

Tustin, California, 92780, United States

RECRUITING

Unknown Facility

Buenos Aires, Argentina

RECRUITING

Unknown Facility

Ashkelon, Israel

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Howard Dittrich, MD

  Sorbent Therapeutics, Study Sponsor

  STUDY CHAIR

Central Study Contacts

Jade Brennan

CONTACT

919-491-5721; jadebrennan@momentum-research.com

Jean Chang

CONTACT

jchang@sorbent.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

AR (1); IL (1); US (1)