Heart FailurePhase 1NCT01598740
Evaluation of CLP With and Without Spironolactone in Heart Failure Patients With Chronic Kidney Disease
A Phase 1 study testing CLP and Spironolactone in people with Heart Failure, run by Sorbent Therapeutics at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CLP and Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure with New York Heart Association (NYHA) Classification II or III
- Chronic kidney disease
- Cardiac ejection fraction <40%
- On heart failure therapy including an ACEI or ARB, and a BB
- Willing to understand and comply with study procedures and provide written informed consent.
Who cannot join
- Hospitalization within 4 weeks of baseline visit
- History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
- Current or anticipated dialysis during study
- In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe
- Drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange Country Research Center
Tustin, California, 92780
About this study
Official title: A Phase 1, Open-label, Randomized, Crossover Study to Assess the Safety, Tolerability, and Efficacy of CLP With and Without Spironolactone in Adults With Heart Failure
The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.
- Conditions
- Heart Failure
- Being tested
- CLP, Spironolactone
- 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
Oral administration
SpironolactoneDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| CLP with spironolactone | Experimental | Not described Receives: Drug: CLP; Drug: Spironolactone |
| CLP without spironolactone | Experimental | Not described Receives: Drug: CLP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fecal Sodium Content
Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
Measured: baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)
Secondary outcomes (1)
Change in Fecal Weight
Change = (Days 10-13/29-32 Daily Average) - (Days 3-6/22-25 Daily Average)
Measured: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
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 SponsorJoel Neutel, MD, Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598740
- Sponsor's protocol ID
- CTST-25
- Status last verified
- Jul 2013
- First submitted
- 11 May 2012
- Last updated
- 19 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, Crossover Study to Assess the Safety, Tolerability, and Efficacy of CLP With and Without Spironolactone in Adults With Heart Failure
- ClinicalTrials.gov ID
- NCT01598740
- Acronym / sponsor ID
- CTST-25
- Conditions
- Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sorbent TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Posted 8 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effects of CLP, with and without spironolactone, on serum, urine, and fecal contents in heart failure patients with chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLP with spironolactone | Experimental | Drug: CLP, Drug: Spironolactone |
| CLP without spironolactone | Experimental | Drug: CLP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Heart failure with New York Heart Association (NYHA) Classification II or III
- Chronic kidney disease
- Cardiac ejection fraction <40%
- On heart failure therapy including an ACEI or ARB, and a BB
- Willing to understand and comply with study procedures and provide written informed consent.
Key exclusion criteria (5 listed)
- Hospitalization within 4 weeks of baseline visit
- History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
- Current or anticipated dialysis during study
- In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological, or other disease or condition that makes the subject's study participation unsafe
- Drug or alcohol abuse
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 |
|---|---|---|
| CLPOral administration | Drug | CLP with spironolactone, CLP without spironolactone |
| Spironolactoneoral administration | Drug | CLP with spironolactone |
Primary outcome
Change in Fecal Sodium Content
Time frame: baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)
Change =(Days 10-13/29-32 Daily Average)-(Days 3-6/22-25 Daily Average)
1 secondary outcome
Change in Fecal Weight
Time frame: baseline average (days 3-6 or 22-25) and treatment average (days 10-13 or 29-32)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Howard Dittrich, MD study chair
Sorbent Therapeutics, Study Sponsor
Joel Neutel, MD principal investigator
Orange County Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CLP and Spironolactone in people with Heart Failure, run by Sorbent Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: finished, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fecal Sodium Content (time frame: baseline average (days 3-6 or days 22-25) and treatment average (days 10-13 or 29-32)). 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 19 Jul 2013.