Heart FailurePhase 2STEPWISENCT01736735
Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
A Phase 2 study testing CLP in people with Heart Failure, run by Sorbent Therapeutics at 3 sites in 3 countries.
Trial summary
This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CLP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 3 countries.
Jean Chang contact
3 sites in 3 countries
United States1 site, 1 recruiting
- Recruiting
Orange Country Research Center
Tustin, California, 92780
Joel Neutel, MD
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.
- Conditions
- Heart Failure
- Being tested
- CLP, placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLPDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| CLP | Experimental | CLP BID Receives: Drug: CLP |
| Placebo | Placebo comparator | BID powder Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8
Secondary outcomes (2)
Change in 6-Minute Walk Test distance from baseline to Week 8.
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorbent Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Dittrich, MD, Study chair, Sorbent Therapeutics, Study Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736735
- Sponsor's protocol ID
- CTST-24
- Acronym
- STEPWISE
- Status last verified
- Mar 2014
- First submitted
- 26 Nov 2012
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects
- ClinicalTrials.gov ID
- NCT01736735
- Acronym / sponsor ID
- STEPWISE / CTST-24
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Sorbent TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLP | Experimental | Drug: CLPCLP BID |
| Placebo | Placebo comparator | Drug: placeboBID powder |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLP | Drug | CLP |
| placebo | Drug | Placebo |
Primary outcome
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
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.
2 secondary outcomes
Change in 6-Minute Walk Test distance from baseline to Week 8.
Time frame: 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
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Chang contact
Howard Dittrich, MD study chair
Sorbent Therapeutics, Study Sponsor
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CLP in people with Heart Failure, run by Sorbent Therapeutics at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Argentina, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jade Brennan (919-491-5721, jadebrennan@momentum-research.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2014.