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Safety Study of Cenderitide in Chronic Stable Heart Failure With Moderate Renal Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02603614
Recruitment Status : Completed
First Posted : November 13, 2015
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Capricor Inc.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Heart Failure Renal Insufficiency Drug: Cenderitide Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : December 2015
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Cenderitide-Placebo

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).

Drug: Cenderitide
Cenderitide is a dual receptor natriuretic peptide.

Drug: Placebo
Placebo control

Experimental: Placebo-Cenderitide

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).

Drug: Cenderitide
Cenderitide is a dual receptor natriuretic peptide.

Drug: Placebo
Placebo control




Primary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. 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. ]
  5. 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. ]
  6. Pharmacodynamics as assessed by observed weight and changes from baseline. [ Time Frame: Evaluated daily during each infusion period (Days -1 - 9) ]
  7. 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) ]
  8. 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. ]
  9. 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. ]
  10. Pharmacodynamics as assessed by observed urinary cGMP and changes from baseline. [ Time Frame: Evaluated daily during each infusion period (Days -1 - 9) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603614


Locations
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United States, California
Orange County Research Center
Tustin, California, United States, 92780
Sponsors and Collaborators
Capricor Inc.
Investigators
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Study Director: Deborah Ascheim, MD Capricor Therapeutics, Inc.
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Responsible Party: Capricor Inc.
ClinicalTrials.gov Identifier: NCT02603614    
Other Study ID Numbers: CDNP-578-02
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Capricor Inc.:
Chronic Heart Failure
Renal Insufficiency
Natriuretic Peptides
Cenderitide
Additional relevant MeSH terms:
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Renal Insufficiency
Heart Failure
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases