Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure (RELAX-REPEAT)

September 21, 2016 updated by: Novartis Pharmaceuticals

Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

The purpose of this study was to assess the safety of repeat doses of serelaxin in chronic heart failure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
321

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Geelong, Australia, 3220
        • Novartis Investigative Site
      • Melbourne, Australia, VIC 3004
        • Novartis Investigative Site
  • Czech Republic
      • Brno - Bohunice, Czech Republic, 625 00
        • Novartis Investigative Site
      • JIhlava, Czech Republic, 586 01
        • Novartis Investigative Site
      • Praha 2, Czech Republic, 128 08
        • Novartis Investigative Site
  • Finland
      • Turku, Finland, 20521
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Berlin, Germany, 13353
        • Novartis Investigative Site
      • Dresden, Germany, 01069
        • Novartis Investigative Site
      • Frankfurt, Germany, 60488
        • Novartis Investigative Site
      • Greifswald, Germany, 17475
        • Novartis Investigative Site
      • Grunstadt, Germany, D-67269
        • Novartis Investigative Site
      • Jena, Germany, 07740
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site
      • Luebeck, Germany, 23562
        • Novartis Investigative Site
      • Magdeburg, Germany, 39112
        • Novartis Investigative Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30159
        • Novartis Investigative Site
  • Italy
    • AR
      • Cortona, AR, Italy, 52044
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
    • MB
      • Monza, MB, Italy, 20900
        • Novartis Investigative Site
    • MI
      • Vimercate, MI, Italy, 200059
        • Novartis Investigative Site
  • Netherlands
      • Groningen, Netherlands
        • Novartis Investigative Site
      • Rotterdam, Netherlands, 3000 CA
        • Novartis Investigative Site
    • The Netherlands
      • Sneek, The Netherlands, Netherlands, 8601 ZR
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway, 0424
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 021659
        • Novartis Investigative Site
      • Bucuresti, Romania, 014461
        • Novartis Investigative Site
      • Craiova, Romania, 200642
        • Novartis Investigative Site
      • Sibiu, Romania, 550245
        • Novartis Investigative Site
    • Mures
      • Targu Mures, Mures, Romania, 540136
        • Novartis Investigative Site
  • Russian Federation
      • Moscow, Russian Federation, 117198
        • Novartis Investigative Site
      • Moscow, Russian Federation, 109469
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28007
        • Novartis Investigative Site
      • Madrid, Spain, 28040
        • Novartis Investigative Site
    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
      • Sevilla, Andalucia, Spain, 41014
        • Novartis Investigative Site
    • Cadiz
      • Villamartin, Cadiz, Spain, 11650
        • Novartis Investigative Site
  • Sweden
      • Stockholm, Sweden, 141 86
        • Novartis Investigative Site
  • Turkey
      • Diskapi / Ankara, Turkey, 06110
        • Novartis Investigative Site
      • Haydarpasa/Istanbul, Turkey, 34668
        • Novartis Investigative Site
      • Kocaeli, Turkey, 41380
        • Novartis Investigative Site
      • Meselik / Eskisehir, Turkey, 26480
        • Novartis Investigative Site
      • Sivas, Turkey, 58140
        • Novartis Investigative Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Novartis Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Novartis Investigative Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Novartis Investigative Site
      • South Miami, Florida, United States, 33143
        • Novartis Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Novartis Investigative Site
      • Minneapolis, Minnesota, United States, 55417
        • Novartis Investigative Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7075
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Novartis Investigative Site
    • Virginia
      • Richmond, Virginia, United States, 23298-0050
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: RLX030 (serelaxin)
Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
Drug: RLX030 (serelaxin)
RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours.
Other Names:
  • RLX030
PLACEBO_COMPARATOR: Placebo
Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
Drug: Placebo
Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 16 weeks

A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.

A patient is considered antibody negative during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were negative. A patient's antibody status is considered to be undetermined during the study if it is not defined as positive or negative.
16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16
A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive. Each time period is defined as the time frame from study drug initiation (or the visit if there is no infusion) to prior to study drug initiation of the next period (or the visit if no there is no infusion). n= The total number of subjects with evaluable antibody status during the defined period.
Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16
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
Time Frame: Week 4, Week 8, Week 12
Week 4, Week 8, Week 12
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)
Time Frame: At Week 4, Week 8, Week 12

A patient is considered antibody positive during the study if he/she had at least two infusions and had at least one evaluable measurement to test for anti-serelaxin antibodies after each infusion and all evaluable antibody test results were positive.

n = the total number of subjects with evaluable antibody status after specified number of infusions
At Week 4, Week 8, Week 12
Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions
Time Frame: 16 weeks
Incidence rate of special interest, indicative of hypersensitivity reactions which occur during and after administration of repeated infusions of serelaxin relative to placebo in subjects with chronic heart failure is reported. Hypersensitivity reactions or infusion reactions can be headache, nausea, fever, chills, dizziness, flush, pruritus, chest and/or back pain.
16 weeks
Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48)
Time Frame: pre-infusion and 8, 24 and 48 hours post each infusion.
Due to sparse PK sampling, AUC 0-48 hours was not analyzed.
pre-infusion and 8, 24 and 48 hours post each infusion.
Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css)
Time Frame: pre-infusion and 24, 48 hours post each infusion
Concentration at steady state (Css) was estimated using C48 or C24 for patients who received the intended rate of infusion for at least 24hours. n: Number of patients with valid PK parameters available
pre-infusion and 24, 48 hours post each infusion
Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours
Time Frame: 48 hours post each infusion
This analysis was not done due to sparse PK sampling.
48 hours post each infusion
Pharmacokinetics of RLX030: Clearance of Serelaxin (CL)
Time Frame: 48 hours post each infusion
Clearance (CL) was calculated using concentration at steady state (Css) and the actual delivered dose rate. n: Number of patients with valid PK parameters available within 48 hours post each infusion.
48 hours post each infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CRLX030A2209
  • 2013-002781-39 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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