Recruiting
Phase 2

CLP

Sponsor:

Sorbent Therapeutics

Code:

NCT01736735

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

CLP

placebo

Study Details

Brief summary:

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

Conditions

Heart Failure

Study ID

NCT01736735

Start date

Jan, 2013

Status verified date

Mar, 2014

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CLP

CLP BID

placebo comparator: Placebo

BID powder

Interventions

CLP

placebo

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Jade Brennan

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

Jean Chang

jchang@sorbent.com

Locations

Orange Country Research Center

Recruiting

Tustin, California, United States, 92780

Principal Investigator:

Joel Neutel, MD

More Information

Sponsor

Sorbent Therapeutics

Last update posted

Mar 5, 2014

Last verified

Mar, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sorbent Therapeutics on 2014-03-05.