Heart FailurePhase 1NCT01316432
PK/PD Study of Subcutaneous Cenderitide Infusion in CHF Patients
A Phase 1 study testing Cenderitide in people with Heart Failure and ADHF, run by Nile Therapeutics at 5 sites in United States.
Trial summary
The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, ADHF, Chronic Heart Failure
- 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
- 58 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2011to Nov 2011
- Phase
- Phase 1
- 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
- Male or female ≥ 18 years of age.
- Documented systolic heart failure with ejection fraction (EF) ≤ 40%
- Clinical evidence of volume overload
- Systolic blood pressure ≥ 120 mmHg and ≤ 200 mmHg and diastolic blood pressure > 60 mmHg and < 110 mmHg at the time of screening.
- Stable doses of oral medication at least 24 hours prior to screening
- No known allergy or contraindication to furosemide (Lasix®)
- Female patients must be post-menopausal or surgically sterile. A woman may be considered to be surgically sterilized if she has had a bilateral tubal ligation (for at least 6 months), bilateral oophorectomy or complete hysterectomy.
- Be adequately informed of the nature and risks of the study and give written informed consent prior to receiving study medication.
Who cannot join
- Acute or suspected acute myocardial infarction (AMI) or troponin levels > 5X the upper limit of normal at the institution's local laboratory and accompanied by dynamic ECG changes consistent with AMI
- Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to screening.
- Evidence of uncorrected volume or sodium depletion (NA ≤ 130) or other condition that would predispose the patient to adverse events.
- Clinically significant aortic or mitral valve stenosis.
- Temperature > 38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment.
- ADHF associated with significant arrhythmias (ventricular tachycardia, bradyarrhythmias with ventricular rate < 45 beats per minute or atrial fibrillation/flutter with ventricular response of > 160 beats per minute).
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- Severe renal failure defined as creatinine clearance < 30 mL/min as estimated by both the Cockcroft-Gault and the Modification of Diet in Renal Disease (MDRD) equations.
- Significant pulmonary disease (history of oral daily steroid dependency, history of CO2 retention or need for intubation for acute exacerbation, or currently receiving IV steroids).
- Any organ transplant recipient, currently listed (anticipated in the next 60 days) for transplant, or admitted for cardiac transplantation.
- Major surgery within 30 days.
- Major neurologic event, including cerebrovascular events in the prior 60 days.
- Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns).
- Known hepatic impairment
- Received an investigational drug within 30 days prior to screening.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity or allergy to natriuretic peptide or its components, nesiritide, other natriuretic peptides or related compounds.
- Any condition which, in the opinion of the Investigator, could interfere with, or for which the treatment might interfere with the conduct of the study, or which would unacceptably increase the risk of the patient's participation in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Analab Clinical Research, Inc.
Lenexa, Kansas, 66219
Benchmark Research
Metairie, Louisiana, 70006
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Study Assessing The Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Subcutaneous Bolus And Subcutaneous Infusion Of Cenderitide In Patients With Chronic Heart Failure With Volume Overload (HF)
The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus.
- Conditions
- Heart Failure, ADHF, Chronic Heart Failure, CHF
- Being tested
- Cenderitide, Placebo
- Keywords
- Cenderitide, CD-NP, Natriuretic peptide, Heart failure, Chronic heart failure, HF, CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenderitideDrug
Also called CD-NP
Cenderitide is a novel rationally designed chimeric natriuretic peptide to be administered in this trial as either a subcutaneous injection or infusion.
PlaceboOther
Placebo will be administered as a 24-hour SQ infusion
| Study group | Role | What they receive |
|---|---|---|
| SQ Bolus Cenderitide | Experimental | Not described Receives: Drug: Cenderitide |
| SQ Infusion Cenderitide | Experimental | 24 hour SQ infusion of cenderitide Receives: Drug: Cenderitide |
| Placebo | Placebo comparator | 24 hrs of SQ placebo infusion Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK)
Pharmacokinetic measurements of subcutaneous cenderitide infusion compared with a subcutaneous bolus administration
Measured: Up to 36 hours
Secondary outcomes (1)
Pharmacodynamics (PD)
Pharmacodynamics, safey and tolerability will be measured by BP, heart rate, and plasma cGMP after administration.
Measured: Up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionNov 2011
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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nile Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316432
- Sponsor's protocol ID
- NIL-CDNP-CT006
- Status last verified
- Oct 2012
- First submitted
- 14 Mar 2011
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Assessing The Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Subcutaneous Bolus And Subcutaneous Infusion Of Cenderitide In Patients With Chronic Heart Failure With Volume Overload (HF)
- ClinicalTrials.gov ID
- NCT01316432
- Acronym / sponsor ID
- NIL-CDNP-CT006
- Conditions
- Heart Failure, ADHF, Chronic Heart Failure, CHF
- Keywords
- Cenderitide, CD-NP, Natriuretic peptide, Heart failure, Chronic heart failure, HF, CHF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Nile TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 16 Mar 2011 (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.
The purposed of the study is to evaluate the pharmacokinetics (PK) response of continuous subcutaneous (SQ) infusion of cenderitide, as compared with a single SQ bolus.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SQ Bolus Cenderitide | Experimental | Drug: Cenderitide |
| SQ Infusion Cenderitide | Experimental | Drug: Cenderitide24 hour SQ infusion of cenderitide |
| Placebo | Placebo comparator | Other: Placebo24 hrs of SQ placebo infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥ 18 years of age.
- Documented systolic heart failure with ejection fraction (EF) ≤ 40%
- Clinical evidence of volume overload
- Systolic blood pressure ≥ 120 mmHg and ≤ 200 mmHg and diastolic blood pressure > 60 mmHg and < 110 mmHg at the time of screening.
- Stable doses of oral medication at least 24 hours prior to screening
Key exclusion criteria (17 listed)
- Acute or suspected acute myocardial infarction (AMI) or troponin levels > 5X the upper limit of normal at the institution's local laboratory and accompanied by dynamic ECG changes consistent with AMI
- Clinical diagnosis of acute coronary syndrome (ACS) within 30 days prior to screening.
- Evidence of uncorrected volume or sodium depletion (NA ≤ 130) or other condition that would predispose the patient to adverse events.
- Clinically significant aortic or mitral valve stenosis.
- Temperature > 38°C (oral or equivalent), sepsis or active infection requiring IV anti-microbial treatment.
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 |
|---|---|---|
| CenderitideAlso: CD-NPCenderitide is a novel rationally designed chimeric natriuretic peptide to be administered in this trial as either a subcutaneous injection or infusion. | Drug | SQ Bolus Cenderitide, SQ Infusion Cenderitide |
| PlaceboPlacebo will be administered as a 24-hour SQ infusion | Other | Placebo |
Primary outcome
Pharmacokinetics (PK)
Time frame: Up to 36 hours
Pharmacokinetic measurements of subcutaneous cenderitide infusion compared with a subcutaneous bolus administration
1 secondary outcome
Pharmacodynamics (PD)
Time frame: Up to 36 hours
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 18 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cenderitide in people with Heart Failure and ADHF, run by Nile Therapeutics at 5 sites 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 8 inclusion and 17 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 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 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?
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?
Pharmacokinetics (PK) (time frame: Up to 36 hours). 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 18 Oct 2012.