Renal Hemodynamic Effects of RLX030A in Subjects With Chronic Heart Failure (CHF)

December 11, 2020 updated by: Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Renal Hemodynamic Effects of RLX030 and Placebo Infused for 24 Hours in Subjects With Chronic Heart Failure (CHF)

This study will assess the renal hemodynamic effect of RLX030 infusion in subjects with chronic heart failure. In addition safety and effects on renal function and biomarkers will be assessed.

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.
118

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

  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Novartis Investigative Site
      • Goettingen, Germany, 37075
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
  • Netherlands
      • Deventer, Netherlands, 7416 SE
        • Novartis Investigative Site
      • Groningen, Netherlands, 9713 GZ
        • Novartis Investigative Site
      • Sneek, Netherlands, 8601 ZR
        • Novartis Investigative Site
  • Poland
      • Grodzisk Mazowiecki, Poland, 05-825
        • Novartis Investigative Site
      • Katowice, Poland, 40-637
        • Novartis Investigative Site
      • Krakow, Poland, 31-202
        • Novartis Investigative Site
      • Kraków, Poland, 31-501
        • Novartis Investigative Site
      • Lublin, Poland, 20-954
        • Novartis Investigative Site
      • Walbrzych, Poland, 58-309
        • Novartis Investigative Site
      • Warszawa, Poland, 04-628
        • Novartis Investigative Site
  • United States
    • Maryland
      • Baltimore, Maryland, United States
        • 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

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female heart failure patients with body weight <160 kg, on standard therapy including a stable dose of furosemide 40-240 mg/day orally (p.o). or equivalent dose of loop diuretics, reduced systolic function (LVEF ≤ 45% measured within the past 6 months), BNP ≥ 100 pg/mL or NT-pro-BNP of ≥ 400 pg/mLNYHA Class II or III, and worsening symptoms, e.g. fatigue, dyspnea, breathlessness within 3 months
  • Mild to moderate renal impairment

Exclusion criteria:

  • Systolic blood pressure (SBP) < 110 mm Hg at the time of randomization
  • Administration of intravenous radiographic contrast agent within 72 hours prior to randomization or acute contrast-induced nephropathy at the time of randomization
  • Current use of non-steroidal antiinflammatory drugs (NSAIDs)
  • Current or planned (through the completion of study drug infusion) treatment with any i.v. therapies, including vasodilators (including nesiritide), positive inotropic agents, vasopressors, levosimendan, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device).
  • Clinically significant hepatic impairment defined as hepatic encephalopathy of any degree or total bilirubin > 50 μmol/l (3 mg/dl) or, if patient is not on warfarin therapy, INR > 2.0 (or Prothrombin Time > 2 * ULN)

Other protocol-defined inclusion/exclusion criteria may apply.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • 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
RLX030 as intravenous infusion for 24 hours.
Drug: RLX030
RLX030 as intravenous infusion for 24 hours.
Placebo Comparator: Placebo
Placebo as intravenous infusion for 24 hours.
Drug: Placebo
Intravenous infusion of Placebo over 24 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
Change from baseline in renal plasma flow (RPF) measured by Para-aminohippuric acid (PAH) clearance in subjects with CHF after 24 hours intravenous (i.v) infusion of RLX030
Time Frame: Baseline, during and after the end of 24 hours infusion
Serial blood and urine collections over time for determination of PAH and its clearance respectively
Baseline, during and after the end of 24 hours infusion
Change from baseline in glomerular filtration rate (GFR) as measured by Iothalamate (IOTH) clearance in subjects with CHF after 24 hours i.v. infusion of RLX030
Time Frame: Baseline, during and after the end of 24 hours infusion
Serial blood and urine collections over time for determination of IOTH and its clearance respectively
Baseline, during and after the end of 24 hours infusion

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
Change from baseline in filtration fraction (FF) in subjects with CHF after 24 hours infusion of RLX030
Time Frame: Baseline, during and after the end of 24 hours of infusion
The filtration fraction (FF) is derived as the ratio of GFR divided by RBF in percent.
Baseline, during and after the end of 24 hours of infusion
Change over time in Diuresis
Time Frame: During 24 hours of infusion and after the end of the infusion
Urine samples will be collected for analyses.
During 24 hours of infusion and after the end of the infusion
Change over time in calculated creatinine clearance
Time Frame: During 24 hours of infusion and after the end of the infusion
Urine samples will be collected for analyses.
During 24 hours of infusion and after the end of the infusion
Change over time on fractional sodium excretion(natriuresis)
Time Frame: During 24 hours of infusion and after the end of the infusion
Urine samples will be collected for analyses.
During 24 hours of infusion and after the end of the infusion
Central aortic systolic pressure-time curve
Time Frame: During 24 hours of infusion and after the end of the infusion
A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms
During 24 hours of infusion and after the end of the infusion
Radial augmentation index-time curve
Time Frame: During 24 hours of infusion and after the end of the infusion
A cuff will be used for a brachial blood pressure measurement and a wrist sensor for arterial pulse waveforms
During 24 hours of infusion and after the end of the infusion
Number of patients with adverse events, serious adverse events and death
Time Frame: During 24 hours of infusion and after the end of the infusion
Monitoring of adverse events, serious adverse events and death from screening to end of study
During 24 hours of infusion and after the end of the infusion
Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to infinity (AUCinf)Time
Time Frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
During 24 hours of infusion and for 24 hours after the end of infusion
Pharmacokinetics of RLX030: area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)
Time Frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
During 24 hours of infusion and for 24 hours after the end of infusion
Pharmacokinetics of RLX030: serum concentration over 20 hours of infusion (C24h)
Time Frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
During 24 hours of infusion and for 24 hours after the end of infusion
Pharmacokinetics of RLX030: terminal elimination half-life (T1/2)following intravenous administration
Time Frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
During 24 hours of infusion and for 24 hours after the end of infusion
Pharmacokinetics of RLX030: mean residence time (MRT)intravenous administration
Time Frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
During 24 hours of infusion and for 24 hours after the end of infusion
Pharmacokinetics of RLX030: volume of distribution at steady state (Vss) following intravenous administration
Time Frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
During 24 hours of infusion and for 24 hours after the end of infusion
Pharmacokinetics of RLX030: systemic clearance from serum (CL) following intravenous administration(natriuresis)
Time Frame: During 24 hours of infusion and for 24 hours after the end of infusion
Blood will be collected from an indwelling catheter.
During 24 hours of infusion and for 24 hours after the end of infusion
Corrected QT (QTc) Interval Using Fridericia's and Bazett's Formula
Time Frame: Baseline, during the 24 hours of infusion and after the end of the infusion
Continuous 12 lead Holter ECG monitoring for extraction of ECGs and analysis
Baseline, during the 24 hours of infusion and after the end of the 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

Helpful Links

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.
February 1, 2012

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.
December 1, 2012

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.
December 1, 2012

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).
March 2, 2012

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.
March 6, 2012

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.
March 7, 2012

Study Record Updates

Last Update Posted (Actual)

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.
December 19, 2020

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.
December 11, 2020

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.
February 1, 2013

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.
  • CRLX030A2202
  • 2011-001588-37 (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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