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

Primary Purpose

Heart Failure, Renal Insufficiency

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cenderitide

Placebo

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Chronic Heart Failure, Renal Insufficiency, Natriuretic Peptides, Cenderitide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Orange County Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cenderitide-Placebo

Placebo-Cenderitide

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.

Pharmacokinetics of cenderitide by assessing Cmax

Pharmacokinetics of cenderitide by assessing tmax

Pharmacokinetics of cenderitide by assessing AUC(0-discharge)

Pharmacodynamics as assessed by observed vital signs and changes from baseline.

Pharmacodynamics as assessed by observed weight and changes from baseline.

Pharmacodynamics as assessed by daily volume difference between liquid intake and urine output (i.e., daily fluid balance) and changes from baseline.

Pharmacodynamics as assessed by observed plasma cystatin C and changes from baseline.

Pharmacodynamics as assessed by observed plasma cGMP and changes from baseline.

Pharmacodynamics as assessed by observed urinary cGMP and changes from baseline.

Secondary Outcome Measures

Full Information

NCT ID

NCT02603614

First Posted

November 5, 2015

Last Updated

February 6, 2020

Sponsor

Capricor Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02603614

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

March 31, 2016 (Actual)

Study Completion Date

March 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Capricor Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Renal Insufficiency

Keywords

Chronic Heart Failure, Renal Insufficiency, Natriuretic Peptides, Cenderitide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cenderitide-Placebo

Arm Type

Experimental

Arm Description

Arm Title

Placebo-Cenderitide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Cenderitide

Intervention Description

Cenderitide is a dual receptor natriuretic peptide.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo control

Primary Outcome Measure Information:

Title

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.

Title

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.

Title

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.

Title

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.

Title

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.

Title

Pharmacodynamics as assessed by observed weight and changes from baseline.

Time Frame

Evaluated daily during each infusion period (Days -1 - 9)

Title

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)

Title

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.

Title

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.

Title

Pharmacodynamics as assessed by observed urinary cGMP and changes from baseline.

Time Frame

Evaluated daily during each infusion period (Days -1 - 9)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah Ascheim, MD

Organizational Affiliation

Capricor Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Orange County Research Center

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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