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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenderitide | Drug | Cenderitide is a dual receptor natriuretic peptide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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) | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Ascheim, MD | Capricor Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C575835 | cenderitide |
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| Placebo | Drug | Placebo control |
|
| Evaluated daily during each infusion period (Days -1 - 9) |
| Pharmacodynamics as assessed by observed plasma cystatin C and changes from baseline. | 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. | 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. | Evaluated daily during each infusion period (Days -1 - 9) |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |