Phase 2
Completed N=323
Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
Source: ClinicalTrials.gov NCT01982292 ↗Enrolled (actual)
323
Serious AEs
14.1%
Results posted
Nov 2016
Primary outcomePrimary: Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks — 0.50; 0.00; 99.50; 100 Percentage of participants — p=>0.9999
Summary
The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Chronic Heart Failure (CHF) Who Develop Anti-serelaxin Antibodies at Any Time Following Repeat Administration of IV Continuous Infusions of Serelaxin Administered for up to 48 Hours in 16 Weeks |
0.50; 0.00; 99.50; 100 | >0.9999 |
| SECONDARY Percentage of Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies After a Single Infusion of Serelaxin Over Time up to Week 16 |
0.48; 0.00; 0.49; 0.00; 0.49; 0.00 | — |
| SECONDARY Antibody Titers in Participants With Chronic Heart Failure Who Develop Positive Anti-serelaxin Antibodies (Neutralizing, Non-neutralizing or Both) at Any Time Following 3 Repeated Infusions and at Week 4, Week 8 and Week 12 |
NA | — |
| SECONDARY Percentage of Participants With Chronic Heart Failure With Positive Antibody Status Who Develop Non-neutralizing Anti-serelaxin Antibodies Following 3 Repeated Infusions (i.e. at Week 4, Week 8, and Week 12) |
0.48; 0.0; 0.50; 0.0; 0.54; 0.0 | — |
| SECONDARY Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions |
32; 14; 32; 14; 0; 0 | — |
| SECONDARY Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48) |
— | — |
| SECONDARY Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css) |
31.6; 53.5; 38.9 | — |
| SECONDARY Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours |
— | — |
| SECONDARY Pharmacokinetics of RLX030: Clearance of Serelaxin (CL) |
106; 97.4; 202 | — |
Eligibility Criteria
Key Inclusion Criteria
- Body weight of ≤ 160 kg.
- Subjects with compensated CHF (NYHA Class II - III) at time of screening with a prior documented history of chronic heart failure.
- NT-proBNP >300 pg/ml (according to central measurement) at visit 1.
- Subjects treated with appropriate and guideline-indicated CHF standard of care.
- Ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.
Key Exclusion Criteria
- Current acute decompensated HF
- Any major solid organ transplant recipient or planned anticipated organ transplant within 1 year.
- Documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without ICD (implantable cardioverter defibrillator) with significant hemodynamic consequences within the 3 months prior to screening.
- Presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
- Subjects with severe renal impairment defined as pre-randomization eGFR < 30 ml/min/1.73m2 calculated using the sMDRD equation and/or those receiving current or planned dialysis or ultrafiltration
Data sourced from ClinicalTrials.gov (NCT01982292). 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.