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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001588-37 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RLX030 | Experimental | RLX030 as intravenous infusion for 24 hours. |
|
| Placebo | Placebo Comparator | Placebo as intravenous infusion for 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RLX030 | Drug | RLX030 as intravenous infusion for 24 hours. |
| |
| Placebo |
| 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in filtration fraction (FF) in subjects with CHF after 24 hours infusion of RLX030 | 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 |
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Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Baltimore | Maryland | United States | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25286914 | Derived | Voors AA, Dahlke M, Meyer S, Stepinska J, Gottlieb SS, Jones A, Zhang Y, Laurent D, Slart RH, Navis GJ. Renal hemodynamic effects of serelaxin in patients with chronic heart failure: a randomized, placebo-controlled study. Circ Heart Fail. 2014 Nov;7(6):994-1002. doi: 10.1161/CIRCHEARTFAILURE.114.001536. Epub 2014 Oct 6. |
| Label | URL |
|---|---|
| Results for CRLX030A2202 from the Novartis Clinical Trials website | View source |
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| Drug |
Intravenous infusion of Placebo over 24 hours |
|
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 | 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) | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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) | 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 | 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 |
| Berlin |
| 10117 |
| Germany |
| Novartis Investigative Site | Erlangen | 91054 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Deventer | 7416 SE | Netherlands |
| Novartis Investigative Site | Groningen | 9713 GZ | Netherlands |
| Novartis Investigative Site | Sneek | 8601 ZR | Netherlands |
| Novartis Investigative Site | Grodzisk Mazowiecki | 05-825 | Poland |
| Novartis Investigative Site | Katowice | 40-637 | Poland |
| Novartis Investigative Site | Krakow | 31-202 | Poland |
| Novartis Investigative Site | Krakow | 31-501 | Poland |
| Novartis Investigative Site | Lublin | 20-954 | Poland |
| Novartis Investigative Site | Warsaw | 04-628 | Poland |
| Novartis Investigative Site | Wałbrzych | 58-309 | Poland |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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