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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01982292




Registration number
NCT01982292
Ethics application status
Date submitted
6/11/2013
Date registered
13/11/2013
Date last updated
9/11/2016

Titles & IDs
Public title
Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
Scientific title
Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
Secondary ID [1] 0 0
2013-002781-39
Secondary ID [2] 0 0
CRLX030A2209
Universal Trial Number (UTN)
Trial acronym
RELAX-REPEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RLX030 (serelaxin)
Treatment: Drugs - Placebo

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

Placebo comparator: Placebo - Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8


Treatment: Drugs: 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.

Treatment: Drugs: Placebo
Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Randomization to Week 4, Week 4 to Week 8, Week 8 to Week 12, week 12 to week 16
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Week 4, Week 8, Week 12
Secondary outcome [3] 0 0
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)
Timepoint [3] 0 0
At Week 4, Week 8, Week 12
Secondary outcome [4] 0 0
Number of Participants With Adverse Events Such as Adjudicated Potential Hypersensitivity or Infusion Reactions
Timepoint [4] 0 0
16 weeks
Secondary outcome [5] 0 0
Pharmacokinetics of RLX030: Area Under the Plasma Concentration Time Curve From Time Zero up to 48 Hours Post Dose (AUC 0-48)
Timepoint [5] 0 0
pre-infusion and 8, 24 and 48 hours post each infusion.
Secondary outcome [6] 0 0
Pharmacokinetics of RLXL030: Actual Concentrations at Steady State (Css)
Timepoint [6] 0 0
pre-infusion and 24, 48 hours post each infusion
Secondary outcome [7] 0 0
Pharmacokinetics of RLX030: Cmax Steady State (Cmaxss) Concentration at 48 Hours
Timepoint [7] 0 0
48 hours post each infusion
Secondary outcome [8] 0 0
Pharmacokinetics of RLX030: Clearance of Serelaxin (CL)
Timepoint [8] 0 0
48 hours post each infusion

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
321
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Geelong
Recruitment hospital [2] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
VIC 3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Virginia
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Brno - Bohunice
Country [9] 0 0
Czech Republic
State/province [9] 0 0
JIhlava
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Praha 2
Country [11] 0 0
Finland
State/province [11] 0 0
Turku
Country [12] 0 0
Germany
State/province [12] 0 0
Niedersachsen
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Dresden
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Greifswald
Country [17] 0 0
Germany
State/province [17] 0 0
Grunstadt
Country [18] 0 0
Germany
State/province [18] 0 0
Jena
Country [19] 0 0
Germany
State/province [19] 0 0
Kiel
Country [20] 0 0
Germany
State/province [20] 0 0
Luebeck
Country [21] 0 0
Germany
State/province [21] 0 0
Magdeburg
Country [22] 0 0
Italy
State/province [22] 0 0
AR
Country [23] 0 0
Italy
State/province [23] 0 0
BS
Country [24] 0 0
Italy
State/province [24] 0 0
MB
Country [25] 0 0
Italy
State/province [25] 0 0
MI
Country [26] 0 0
Netherlands
State/province [26] 0 0
The Netherlands
Country [27] 0 0
Netherlands
State/province [27] 0 0
Groningen
Country [28] 0 0
Netherlands
State/province [28] 0 0
Rotterdam
Country [29] 0 0
Norway
State/province [29] 0 0
Oslo
Country [30] 0 0
Romania
State/province [30] 0 0
Mures
Country [31] 0 0
Romania
State/province [31] 0 0
Bucharest
Country [32] 0 0
Romania
State/province [32] 0 0
Bucuresti
Country [33] 0 0
Romania
State/province [33] 0 0
Craiova
Country [34] 0 0
Romania
State/province [34] 0 0
Sibiu
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Moscow
Country [36] 0 0
Spain
State/province [36] 0 0
Andalucia
Country [37] 0 0
Spain
State/province [37] 0 0
Cadiz
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Sweden
State/province [39] 0 0
Stockholm
Country [40] 0 0
Turkey
State/province [40] 0 0
Diskapi / Ankara
Country [41] 0 0
Turkey
State/province [41] 0 0
Haydarpasa/Istanbul
Country [42] 0 0
Turkey
State/province [42] 0 0
Kocaeli
Country [43] 0 0
Turkey
State/province [43] 0 0
Meselik / Eskisehir
Country [44] 0 0
Turkey
State/province [44] 0 0
Sivas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01982292