Heart FailurePhase 1/2NCT02603614
Safety Study of Cenderitide in Chronic Stable Heart Failure With Moderate Renal Impairment
A Phase 1/2 study testing Cenderitide in people with Heart Failure and Renal Insufficiency, run by Capricor Inc. at 1 site in United States.
Trial summary
CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate renal impairment will be randomized (1:1) to receive cenderitide or placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Renal Insufficiency
- What is being tested?
- Cenderitide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 31 Mar 2016
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent after reviewing the design and risks of the study and prior to completing any study-related procedure
- Willing and able to understand and comply with all study procedures and requirements, including in-patient stay
- Current or historical New York Heart Association (NYHA) functional class ≥ II
- Glomerular Filtration Rate (GFR) ≥ 30 and ≤ 60 mL/min at the time of screening
- Systolic blood pressure 120-160 mmHg at the time of screening
- Stable and compliant treatment with oral medications for at least 4 weeks prior to screening
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- Body Mass Index (BMI) ≥18 and ≤45 kg/m2 at the time of screening
- Women of child bearing potential (WOCBP) and males must agree to use at least two forms of contraception, of which one includes a barrier method (male condom) by the male partner, during study participation and continued for at least 90 days after the conclusion of the final infusion rate. In addition, sperm donations by male subjects are not permitted during the subject's participation in the research study and for at least 90 days after the conclusion of the final infusion rate. This criterion may be waived for male subjects who have undergone a vasectomy at least 6 months prior to screening
- Willing and able to abstain from drugs, alcohol, and tobacco during study participation
Who cannot join
- Hypersensitivity or allergy to natriuretic peptides
- Acute decompensated heart failure (ADHF) within 30 days prior to randomization
- Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to randomization
- Symptomatic postural hypotension
- Concomitant medication of an aldosterone blocker (e.g., eplerenone or spironolactone) within 30 days prior to randomization
- Potassium of ≥ 5.0 mmol/L
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- Evidence of uncorrected volume or sodium ≤ 130 mmol/L within 24 hours prior to randomization
- Clinically significant aortic or mitral valve stenosis
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
- Significant pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Dose Escalating, Cross Over Designed Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Open-Label, Continuous Subcutaneous Infusion of Cenderitide Via the Insulet Drug Delivery System in Chronic Stable Heart Failure Subjects With Moderate Renal Impairment
CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate renal impairment will be randomized (1:1) to receive cenderitide or placebo. Enrolled subjects will begin with Infusion Period A where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the Insulet Drug Delivery System. Enrolled subjects will then cross over into Infusion Period B where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo.
- Conditions
- Heart Failure, Renal Insufficiency
- Being tested
- Cenderitide, Placebo
- Keywords
- Chronic Heart Failure, Renal Insufficiency, Natriuretic Peptides, Cenderitide
- Medical subject headings
- Heart Failure, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenderitideDrug
Cenderitide is a dual receptor natriuretic peptide.
PlaceboDrug
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Cenderitide-Placebo | Experimental | Infusion Period A: Cenderitide Infusion Period B: Placebo
This is a randomized, double-blind, placebo-controlled, cross-over trial. The sequence was either cenderitide crossed over to placebo or placebo crossed over to cenderitide, with the sequence divided into two 7-day infusion periods (Infusion Period A and Infusion Period B). Receives: Drug: Cenderitide; Drug: Placebo |
| Placebo-Cenderitide | Experimental | Infusion Period A: Placebo Infusion Period B: Cenderitide
This is a randomized, double-blind, placebo-controlled, cross-over trial. The sequence was either cenderitide crossed over to placebo or placebo crossed over to cenderitide, with the sequence divided into two 7-day infusion periods (Infusion Period A and Infusion Period B). Receives: Drug: Cenderitide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability as evaluated by incidence and severity of treatment-emergent adverse events, concomitant medications, and changes from baseline in lab assessments, vital signs, physical exams, and ECGs per subject and for the study as a whole.
Measured: Evaluated throughout the duration of a subject's participation in the study until 7 days post completion of the final study infusion of cenderitide or placebo.
Pharmacokinetics of cenderitide by assessing Cmax
Measured: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacokinetics of cenderitide by assessing tmax
Measured: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacokinetics of cenderitide by assessing AUC(0-discharge)
Measured: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacodynamics as assessed by observed vital signs and changes from baseline.
Measured: Evaluated throughout the duration of a subject's participation in the study until 7 days post completion of the final study infusion of cenderitide or placebo.
Pharmacodynamics as assessed by observed weight and changes from baseline.
Measured: Evaluated daily during each infusion period (Days -1 - 9)
Pharmacodynamics as assessed by daily volume difference between liquid intake and urine output (i.e., daily fluid balance) and changes from baseline.
Measured: Evaluated daily during each infusion period (Days -1 - 9)
Pharmacodynamics as assessed by observed plasma cystatin C and changes from baseline.
Measured: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacodynamics as assessed by observed plasma cGMP and changes from baseline.
Measured: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacodynamics as assessed by observed urinary cGMP and changes from baseline.
Measured: Evaluated daily during each infusion period (Days -1 - 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startDec 2015
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capricor Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deborah Ascheim, MD, Study director, Capricor Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603614
- Sponsor's protocol ID
- CDNP-578-02
- Status last verified
- Oct 2018
- First submitted
- 5 Nov 2015
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Dose Escalating, Cross Over Designed Study to Assess the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Open-Label, Continuous Subcutaneous Infusion of Cenderitide Via the Insulet Drug Delivery System in Chronic Stable Heart Failure Subjects With Moderate Renal Impairment
- ClinicalTrials.gov ID
- NCT02603614
- Acronym / sponsor ID
- CDNP-578-02
- Conditions
- Heart Failure, Renal Insufficiency
- Keywords
- Chronic Heart Failure, Renal Insufficiency, Natriuretic Peptides, Cenderitide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Capricor Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 13 Nov 2015 (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.
CNDP-578-02 is a randomized, double-blind, placebo-controlled, dose-escalation, crossover design trial. Eight evaluable subjects (n=8) with chronic stable heart failure and moderate renal impairment will be randomized (1:1) to receive cenderitide or placebo. Enrolled subjects will begin with Infusion Period A where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo via the Insulet Drug Delivery System. Enrolled subjects will then cross over into Infusion Period B where they will receive up to 7 days of continuous, subcutaneous, dose-escalating infusions of cenderitide or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cenderitide-Placebo | Experimental | Drug: Cenderitide, Drug: PlaceboInfusion Period A: Cenderitide Infusion Period B: Placebo This is a randomized, double-blind, placebo-controlled, cross-over trial. The sequence was either cenderitide crossed over to placebo or placebo crossed over to cenderitide, with the sequence divided into two 7-day infusion periods (Infusion Period A and Infusion Period B). |
| Placebo-Cenderitide | Experimental | Drug: Cenderitide, Drug: PlaceboInfusion Period A: Placebo Infusion Period B: Cenderitide This is a randomized, double-blind, placebo-controlled, cross-over trial. The sequence was either cenderitide crossed over to placebo or placebo crossed over to cenderitide, with the sequence divided into two 7-day infusion periods (Infusion Period A and Infusion Period B). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to provide written informed consent after reviewing the design and risks of the study and prior to completing any study-related procedure
- Willing and able to understand and comply with all study procedures and requirements, including in-patient stay
- Current or historical New York Heart Association (NYHA) functional class ≥ II
- Glomerular Filtration Rate (GFR) ≥ 30 and ≤ 60 mL/min at the time of screening
- Systolic blood pressure 120-160 mmHg at the time of screening
Key exclusion criteria (10 listed)
- Hypersensitivity or allergy to natriuretic peptides
- Acute decompensated heart failure (ADHF) within 30 days prior to randomization
- Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to randomization
- Symptomatic postural hypotension
- Concomitant medication of an aldosterone blocker (e.g., eplerenone or spironolactone) within 30 days prior to randomization
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 |
|---|---|---|
| CenderitideCenderitide is a dual receptor natriuretic peptide. | Drug | Cenderitide-Placebo, Placebo-Cenderitide |
| PlaceboPlacebo control | Drug | Cenderitide-Placebo, Placebo-Cenderitide |
Primary outcome
Safety and tolerability as evaluated by incidence and severity of treatment-emergent adverse events, concomitant medications, and changes from baseline in lab assessments, vital signs, physical exams, and ECGs per subject and for the study as a whole.
Time frame: Evaluated throughout the duration of a subject's participation in the study until 7 days post completion of the final study infusion of cenderitide or placebo.
Pharmacokinetics of cenderitide by assessing Cmax
Time frame: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacokinetics of cenderitide by assessing tmax
Time frame: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacokinetics of cenderitide by assessing AUC(0-discharge)
Time frame: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacodynamics as assessed by observed vital signs and changes from baseline.
Time frame: Evaluated throughout the duration of a subject's participation in the study until 7 days post completion of the final study infusion of cenderitide or placebo.
Pharmacodynamics as assessed by observed weight and changes from baseline.
Time frame: Evaluated daily during each infusion period (Days -1 - 9)
Pharmacodynamics as assessed by daily volume difference between liquid intake and urine output (i.e., daily fluid balance) and changes from baseline.
Time frame: Evaluated daily during each infusion period (Days -1 - 9)
Pharmacodynamics as assessed by observed plasma cystatin C and changes from baseline.
Time frame: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacodynamics as assessed by observed plasma cGMP and changes from baseline.
Time frame: Pre-dose baseline, 24, 48, 72, 96, 120, 144, 168 hours after the start of the infusion period, and 4 and 24 hours post conclusion of the infusion period.
Pharmacodynamics as assessed by observed urinary cGMP and changes from baseline.
Time frame: Evaluated daily during each infusion period (Days -1 - 9)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Deborah Ascheim, MD study director
Capricor Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cenderitide in people with Heart Failure and Renal Insufficiency, run by Capricor Inc. 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 9 inclusion and 10 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 11 Feb 2020. 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability as evaluated by incidence and severity of treatment-emergent adverse events, concomitant medications, and changes from baseline in lab assessments, vital signs, physical exams, and ECGs per subject and for the study as a whole. (time frame: Evaluated throughout the duration of a subject's participation in the study until 7 days post completion of the final study infusion of cenderitide or placebo.). The study lists 10 primary outcomes in all. 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 11 Feb 2020.