A Double-Blind, Placebo-Controlled, Randomized, Multi-Center, Dose-Finding Study of SLV320, a Selective A1 Adenosine Receptor Antagonist, to Evaluate the Effect on Renal Function and Safety in Subjects Hospitalized With Acute Decompensated Heart Failure and Renal Dysfunction (Reno-Defend 1)

Solvay Pharmaceuticals105 sites in 6 countries46 target enrollmentFebruary 2009

ConditionsAcute Decompensated Heart Failure; Renal Dysfunction

InterventionsSLV320 Placebo

DrugsSLV320 Placebo

Overview

Phase: Phase 2
Intervention: SLV320
Conditions: Acute Decompensated Heart Failure; Renal Dysfunction
Sponsor: Solvay Pharmaceuticals
Enrollment: 46
Locations: 105
Primary Endpoint: Change in serum creatinine from baseline to Day 14
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

Detailed Description

The purpose of this study is to determine the efficacy and safety of IV SLV320 in acute heart failure patients with renal dysfunction.

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

January 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Solvay Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: SLV320

2

Intervention: SLV320

3

Intervention: SLV320

4

Intervention: SLV320

5

Intervention: Placebo

Outcomes

Primary Outcomes

Change in serum creatinine from baseline to Day 14

Time Frame: Day 14

Secondary Outcomes

To compare four SLV320 doses to placebo on the change in the following variables: Dyspnea (Likert Scale and PDA scale), eGFR (MDRD Formula), Subject Global Clinical Assessment Score, Urine Osmolality, Serum Osmolality(Up to Day 3 (Dyspnea); Up to Day 4 (Urine Osmolality); Up to Day 60 (eGFR, Subject Global Clinical Assessment Score, Serum Osmolality))
To compare the effect of four I.V. doses of SLV320 with placebo using the trichotomous endpoint of treatment success, treatment failure, or no change(Up to Day 14)
To compare the effect of four I.V. doses of SLV320 with placebo on top of diuretic use(Up to Day 3)
To compare the effect of four I.V. doses of SLV320 with placebo using a composite endpoint of all-cause mortality, cardiovascular hospitalization or hospitalization for worsening renal function, in time to event and frequency(Up to Day 180)
To determine the pharmacokinetic profile of I.V. SLV320(Up to Day 3)