Phase 2
Completed N=26
A Study of CLR325 in Chronic Stable Heart Failure Patients.
Chronic Stable Heart Failure
Source: ClinicalTrials.gov NCT02696967 ↗
Enrolled (actual)
26
Serious AEs
15.4%
Results posted
Mar 2020
Primary outcomePrimary: Number of Patients With Adverse Events, Serious Adverse Events and Death — 1; 2; 4; 7 Participants
Summary
The purpose of this study was to determine the safety and tolerability of CLR325 intravenous (i.v.) infusion in patients with stable heart failure to determine if further clinical development of the drug in this indication was warranted.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events, Serious Adverse Events and Death |
1; 2; 4; 7; 0; 2 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to 18 Hours (AUC0-18hr) |
1220; 18500; 79700; NA; 623; 5560 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From From Time Zero to 28 Hours (AUC0-28hrs) |
1460; 21500; 100000; NA; 838; 8390 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) |
1510; 21900; 103000; 843; 9660 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) |
1450; 21500; 100000; 3.10; 836; 8380 | — |
| SECONDARY Pharmacokinetic of CLR325: Clearance From Plasma (CL) Following Drug Administration |
15200; 13200; 7460 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax,ss) |
103; 1370; 6080; NA; 54.2; 468 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Terminal Elimination Half-life (T1/2) |
1.86; 2.99; 2.96; 3.12; 5.73 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Time to Reach the Maximum Concentration After Drug Administration (TMax) |
14.0; 12.0; 14.9; 0; 15.1; 17.9 | — |
| SECONDARY Pharmacokinetic of CLR325: Volume of Distribution at Steady State Following Intravenous Administration (Vss) |
51600; 32500; 28000 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Amount of Drug (or Defined Metabolite) Excreted Into the Urine From Time (Ae 0-28 Hours) |
NA; 19500000; 41300000; NA; 7620000; 4040000 | — |
| SECONDARY Pharmacokinetic of CLR325 and CQJ295: Renal Clearance From Plasma (CLr) Following Drug Administration |
NA; 904; 411; NA; 5620; 258 | — |
| SECONDARY Number of Patients With Increase in Anti-CLR325 and Anti-apelin Antibodies in Serum |
0; 0; 0; 0; 1; 1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Male and female patients >18 years of age
- Body weight between 50 kg and 140 kg
- Cardiac ejection fraction of ≤ 45% assessed within the last 6 months
- For PA catheter cohorts, patients who are planned to have a clinically indicated pulmonary artery catheter in place prior to randomization
- In the opinion of the investigator, heart failure patients who do not require a change in their dose of acetylcholinesterase (ACE), angiotensin receptor blocker (ARB), β-blocker, mineralocorticoid receptor antagonist, or diuretic for 24 h after randomization.
- At Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) assessment in the supine position after the subject has rested for at least five minutes.
Key Exclusion Criteria
- Impaired renal function as indicated by clinically significant abnormal creatinine values (Estimated glomerular filtration rate (eGFR) 50 mm Hg as determined by echocardiography)
- severe mitral stenosis
- History of acute coronary syndrome within the last 60 days as determined by both clinical and enzymatic criteria
- For echocardiography-based cohorts only, patients admitted to an inpatient setting for acute decompensated heart failure within the last 30 days
- For PA catheter cohorts, patients with a pulmonary capillary wedge pressure of <10 mm Hg at Baseline. For echocardiographic cohorts, patients with a lateral E/E' ratio of < 7 on their baseline echocardiogram. For patients in whom a lateral E/E' ratio cannot be determined (e.g., patients in atrial fibrillation), a central venous pressure of < 5 mm Hg on baseline echocardiogram as determined by inferior vena cava criteria.
Data sourced from ClinicalTrials.gov (NCT02696967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.