Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00443690
Status:
COMPLETED
Last Update Posted:
2009-02-20
First Post:
2007-03-02
Brief Title:
Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV Therapy
Sponsor:
NovaCardia Inc a subsidiary of Merck Co Inc Rahway New Jersey USA
Organization:
NovaCardia Inc a subsidiary of Merck Co Inc Rahway New Jersey USA
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study of the Effects of KW-3902 Injectable Emulsion on Heart Failure Signs and Symptoms Diuresis Renal Function and Clinical Outcomes in Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring Intravenous Therapy
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACH UP
Brief Summary:
To evaluate the effect of KW-3902IV in addition to standard therapy on the proportion of worsening heart failure and worsening renal function and on the proportion of deaths or rehospitalizations for heart failure or worsening renal function and to estimate and compare within-trial medical resource utilization and direct medical costs between subjects treated with KW 3902IV versus placebo
Detailed Description:
Loop diuretics are generally first line therapy in patients hospitalized with acute heart failure syndrome AHFS Their use far exceeds that of vasoactive agents Tubuloglomerular feedback TGF is the bodys compensatory response to avoid excess fluid loss and it is activated when elevated sodium concentrations in the distal tubule are detected TGF is proposed as a contributing factor for the observed diuretic resistance that occurs in patients with heart failure Higher doses of diuretics are required to overcome the decreased natriuresis and reduced RBF induced by TGF Ultimately this action creates a vicious cycle of worsening renal function and diminished diuretic effectiveness
The primary pharmacologic rationale for the use of KW-3902 in subjects with AHFS is its mechanism of action as an adenosine A1 receptor antagonist TGF promotes release of adenosine and adenosine binding to A1 receptors causes vasoconstriction of the afferent arteriole decreased RBF and enhanced sodium reabsorption by the proximal tubule This action results in a decrease in GFR diminished renal function and sodium and water retention Blocking adenosine A1 receptors via a selective adenosine receptor antagonist may limit sodium reabsorption by the proximal tubules without triggering TGF It promotes vasodilation of the afferent arteriole of the glomerulus and thus this strategy offers the potential to overcome diuretic resistance or enhance diuretic responsiveness It may also reduce the need for increasing diuretic doses that have been associated with worse outcomes
The primary pharmacologic rationale for the use of KW-3902 in subjects with AHFS is its mechanism of action as an adenosine A1 receptor antagonist TGF promotes release of adenosine and adenosine binding to A1 receptors causes vasoconstriction of the afferent arteriole decreased RBF and enhanced sodium reabsorption by the proximal tubule This action results in a decrease in GFR diminished renal function and sodium and water retention Blocking adenosine A1 receptors via a selective adenosine receptor antagonist may limit sodium reabsorption by the proximal tubules without triggering TGF It promotes vasodilation of the afferent arteriole of the glomerulus and thus this strategy offers the potential to overcome diuretic resistance or enhance diuretic responsiveness It may also reduce the need for increasing diuretic doses that have been associated with worse outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007_805 | None | None | None |
| MK7418-303 | None | None | None |