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Chronic Heart FailurePhase 2RELAX-REPEATNCT01982292

Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure

A Phase 2 study testing RLX030 (serelaxin) in people with Chronic Heart Failure, run by Novartis Pharmaceuticals at 52 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Heart Failure
What is being tested?
RLX030 (serelaxin)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
52 sitesin 13 countries
Study dates
May 2014to Sep 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

52 sites in 13 countries.

52 sites in 13 countries

Germany11 sites

  • Novartis Investigative Site

    Berlin, State of Berlin, 10117

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Dresden, 01069

  • Novartis Investigative Site

    Frankfurt, 60488

  • Novartis Investigative Site

    Greifswald, 17475

  • Novartis Investigative Site

    Grünstadt, D-67269

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30159

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Lübeck, Germany, 23562

  • Novartis Investigative Site

    Magdeburg, 39112

Other trials in Germany

United States9 sites

  • Novartis Investigative Site

    Anaheim, California, 92801

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599-7075

  • Novartis Investigative Site

    Colorado Springs, Colorado, 80918

  • Novartis Investigative Site

    Jacksonville, Florida, 32216

  • Novartis Investigative Site

    Knoxville, Tennessee, 37920

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55404

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55417

  • Novartis Investigative Site

    Richmond, Virginia, 23298-0050

  • Novartis Investigative Site

    South Miami, Florida, 33143

Other trials in United States

Romania5 sites

  • Novartis Investigative Site

    Bucharest, Romania, 014461

  • Novartis Investigative Site

    Bucharest, 021659

  • Novartis Investigative Site

    Craiova, 200642

  • Novartis Investigative Site

    Sibiu, 550245

  • Novartis Investigative Site

    Târgu Mureş, Mureș County, 540136

Other trials in Romania

Spain5 sites

  • Novartis Investigative Site

    Madrid, Madrid, 28007

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Villamartín, Cadiz, 11650

Other trials in Spain

Turkey (Türkiye)5 sites

  • Novartis Investigative Site

    Diskapi / Ankara, 06110

  • Novartis Investigative Site

    Haydarpasa/Istanbul, 34668

  • Novartis Investigative Site

    Kocaeli, 41380

  • Novartis Investigative Site

    Meselik / Eskisehir, 26480

  • Novartis Investigative Site

    Sivas, 58140

Other trials in Turkey (Türkiye)

Italy4 sites

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Cortona, AR, 52044

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Vimercate, MI, 200059

Other trials in Italy

Czechia3 sites

  • Novartis Investigative Site

    Brno-Bohunice, Czech Republic, 625 00

  • Novartis Investigative Site

    Jihlava, 586 01

  • Novartis Investigative Site

    Prague, 128 08

Other trials in Czechia

Netherlands3 sites

  • Novartis Investigative Site

    Groningen

  • Novartis Investigative Site

    Rotterdam, 3000 CA

  • Novartis Investigative Site

    Sneek, The Netherlands, 8601 ZR

Other trials in Netherlands

Australia2 sites

  • Novartis Investigative Site

    Geelong, 3220

  • Novartis Investigative Site

    Melbourne, VIC 3004

Other trials in Australia

Russia2 sites

  • Novartis Investigative Site

    Moscow, 109469

  • Novartis Investigative Site

    Moscow, 117198

Other trials in Russia

Finland1 site

  • Novartis Investigative Site

    Turku, Finland, 20521

Other trials in Finland

Norway1 site

  • Novartis Investigative Site

    Oslo, 0424

Other trials in Norway

Sweden1 site

  • Novartis Investigative Site

    Stockholm, 141 86

Other trials in Sweden

About this study

Official title: 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.

Being tested
RLX030 (serelaxin), Placebo
Keywords
Chronic Heart Failure, CHF, Heart Failure, HF, Immunogenicity, Anti-bodies, Hypersensitivity, Serelaxin, RELAX-REPEAT
Medical subject headings
Heart Failure, Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RLX030 (serelaxin)Drug

    Also called RLX030

    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.

  • PlaceboDrug

    Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.

Study groups in NCT01982292
Study groupRoleWhat they receive
RLX030 (serelaxin)ExperimentalRandomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
Receives: Drug: RLX030 (serelaxin)
PlaceboPlacebo comparatorRandomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: 16 weeks

Secondary outcomes (8)

  1. 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

    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.

    Measured: Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16

  2. 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

    Measured: Week 4, Week 8, Week 12

  3. 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)

    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

    Measured: At Week 4, Week 8, Week 12

  4. Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions

    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.

    Measured: 16 weeks

  5. Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48)

    Due to sparse PK sampling, AUC 0-48 hours was not analyzed.

    Measured: pre-infusion and 8, 24 and 48 hours post each infusion.

  6. Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css)

    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

    Measured: pre-infusion and 24, 48 hours post each infusion

  7. Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours

    This analysis was not done due to sparse PK sampling.

    Measured: 48 hours post each infusion

  8. Pharmacokinetics of RLX030: Clearance of Serelaxin (CL)

    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.

    Measured: 48 hours post each infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2013 (estimated)
  2. Study startMay 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01982292
Sponsor's protocol ID
CRLX030A2209
Other IDs
2013-002781-39
Acronym
RELAX-REPEAT
Status last verified
Sep 2016
First submitted
6 Nov 2013
Last updated
9 Nov 2016
Data monitoring committee
No

Publications

  • Kumar VA, Wilson SS, Ayaz SI, Levy PD. Targeted biological therapies reach the heart: the case of serelaxin for heart failure. Drugs Today (Barc). 2015 Oct;51(10):591-7. doi: 10.1358/dot.2015.51.10.2386731.

    PubMed 26583301

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RLX030 (serelaxin) in people with Chronic Heart Failure, run by Novartis Pharmaceuticals at 52 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Germany, United States, Romania, Spain, Turkey (Türkiye) and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01982292, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.

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