Heart FailurePhase 2NCT01265524
Evaluation of CLP in Heart Failure Patients With Chronic Kidney Disease
A Phase 2 study testing CLP in people with Heart Failure, run by Sorbent Therapeutics at 3 sites in 3 countries.
Trial summary
The purpose of this study is to determine the effects of CLP on serum potassium and signs and symptoms of fluid overload 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Apr 2011to Nov 2011
- Phase
- Phase 2
- 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 III or IV
- Hospitalization for heart failure decompensation associated with fluid overload within the last six months
- Chronic kidney disease
- Must be able to understand study procedures and willing and able to provide written informed consent
Who cannot join
- No hospitalization within 4 weeks of Baseline Visit
- In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological or other disease or condition that makes the patients study participation unsafe
- History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
- Current dialysis patient, or anticipated need for dialysis during study participation
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease
The purpose of this study is to determine the effects of CLP on serum potassium and signs and symptoms of fluid overload in heart failure patients with chronic kidney disease.
- 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
Oral administration
PlaceboDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| CLP | Active comparator | Investigational drug: 15 g CLP per day given as capsules Receives: Drug: CLP |
| Placebo | Placebo comparator | Placebo, capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Potassium
Change in serum potassium from baseline to Week 8.
Measured: Baseline and 8 weeks
Secondary outcomes (6)
Weight Loss at Week 1
Measured: Baseline and 1 week
Weight Loss at Week 2
Measured: Baseline and 2 weeks
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 4.
Measured: 4 weeks
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8
The frequency of marked or disabling exertional dyspnea was physician assessed based on physical exam at week 8.
Measured: 8 weeks
Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8
Measured: Baseline and 8 weeks
6MWT Distance at Week 8
Increase in the 6 minute walk test (6MWT) distance from baseline to Week 8. The test was performed according to the American Thoracic Society (ATS)Guidelines 2002.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startApr 2011
- Primary completionNov 2011
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorbent Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmaterra
- Responsible party
- Sponsor
- Investigators
- Detlef Albrecht, MD, Study chair, Sorbent Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265524
- Sponsor's protocol ID
- CTST-21
- Status last verified
- Mar 2013
- First submitted
- 20 Dec 2010
- Last updated
- 13 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Costanzo MR, Heywood JT, Massie BM, Iwashita J, Henderson L, Mamatsashvili M, Sisakian H, Hayrapetyan H, Sager P, van Veldhuisen DJ, Albrecht D. A double-blind, randomized, parallel, placebo-controlled study examining the effect of cross-linked polyelectrolyte in heart failure patients with chronic kidney disease. Eur J Heart Fail. 2012 Aug;14(8):922-30. doi: 10.1093/eurjhf/hfs074. Epub 2012 May 21.
PubMed 22613585
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Multi-center Study Comparing CLP Versus Placebo in Heart Failure Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01265524
- Acronym / sponsor ID
- CTST-21
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Sorbent TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Pharmaterra
- Study start
- Apr 2011
- Primary completion
- Nov 2011 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 13 Mar 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 on serum potassium and signs and symptoms of fluid overload in heart failure patients with chronic kidney disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLP | Active comparator | Drug: CLPInvestigational drug: 15 g CLP per day given as capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Heart failure with New York Heart Association (NYHA) Classification III or IV
- Hospitalization for heart failure decompensation associated with fluid overload within the last six months
- Chronic kidney disease
- Must be able to understand study procedures and willing and able to provide written informed consent
Key exclusion criteria (4 listed)
- No hospitalization within 4 weeks of Baseline Visit
- In the investigator's judgment, any cardiovascular, renal, hepatic, endocrine, gastrointestinal, neurological or other disease or condition that makes the patients study participation unsafe
- History or presence of gastrointestinal conditions such as severe constipation or gastrointestinal tract strictures
- Current dialysis patient, or anticipated need for dialysis during study participation
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 |
| PlaceboOral administration | Drug | Placebo |
Primary outcome
Change in Serum Potassium
Time frame: Baseline and 8 weeks
Change in serum potassium from baseline to Week 8.
6 secondary outcomes
Weight Loss at Week 1
Time frame: Baseline and 1 week
Weight Loss at Week 2
Time frame: Baseline and 2 weeks
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 4
Time frame: 4 weeks
Frequency of Marked or Disabling Exertional Dyspnea by Physician Assessment at Week 8
Time frame: 8 weeks
Number of Patients Improving by at Least One NYHA Functional Class From Baseline to Week 8
Time frame: Baseline and 8 weeks
6MWT Distance at Week 8
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22613585Costanzo MR, Heywood JT, Massie BM, Iwashita J, Henderson L, Mamatsashvili M, Sisakian H, Hayrapetyan H, Sager P, van Veldhuisen DJ, Albrecht D. A double-blind, randomized, parallel, placebo-controlled study examining the effect of cross-linked polyelectrolyte in heart failure patients with chronic kidney disease. Eur J Heart Fail. 2012 Aug;14(8):922-30. doi: 10.1093/eurjhf/hfs074. Epub 2012 May 21.
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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.
Detlef Albrecht, MD study chair
Sorbent Therapeutics
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?
The sponsor lists 4 inclusion and 4 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 13 Mar 2013. 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 Armenia, Georgia, Moldova. 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?
Yes. Results are posted in the registry (first posted 13 Mar 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 Serum Potassium (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265524, which also lists 1 linked publication.
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 13 Mar 2013.