Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects (STEPWISE)
This study is currently recruiting participants.
Verified April 2013 by Sorbent Therapeutics
Sponsor:
Sorbent Therapeutics
Information provided by (Responsible Party):
Sorbent Therapeutics
ClinicalTrials.gov Identifier:
NCT01736735
First received: November 26, 2012
Last updated: April 9, 2013
Last verified: April 2013
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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 parameters including: 6 MWT, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart failure hospitalization, unscheduled decongestion therapy using IV diuretics or ultrafiltration, or death [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 6 Minute Walk Test [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Dyspnea (visual analog scale) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 270 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (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 at screening:
- Peripheral (or sacral) edema >1+ or ascites
- Pulmonary congestion as determined by chest X-ray
- 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 decongestion therapy using IV diuretics or ultrafiltration within 4 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 4 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 | |
| Not yet 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: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013