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Completed Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT02603614

Public ClinicalTrials.gov record NCT02603614. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 10:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02603614
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Capricor Inc.
Industry
Enrollment
8 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 2015 (Type not available)
Primary completion
Mar 31, 2016 (Actual)
Completion
Mar 31, 2016 (Actual)
Last update posted
Feb 11, 2020

2015 – 2016

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Orange County Research Center Tustin California 92780 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02603614, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 11, 2020 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02603614 live on ClinicalTrials.gov.

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