Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).

A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of the Effects of KW-3902 on Diuresis in Patients With Congestive Heart Failure (CHF) Refractory to High Dose Diuretic Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00159627

Enrollment

Registered

2005-09-12

Start date

2004-08-31

Completion date

Unknown

Last updated

2008-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Keywords

heart failure, congestive, diuretic

Brief summary

The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with volume overload due to CHF who are refractory to high dose diuretic therapy.

Interventions

DRUGKW-3902IV

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* History of CHF for greater than 3 months, * Receiving oral/IV diuretic therapy * Hospitalized for therapy for HF and edema that has not responded to diuretic therapy. * Signs and symptoms of ongoing volume overload

Exclusion criteria

* Myocardial infarction in past 14 days * Clinical evidence of acute coronary syndrome causing worsening of HF, * Pregnant or breast-feeding, * Severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy, * Automated implanted cardiac defibrillator (AICD) or synchronization device implanted within the preceding 7 days, * Require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment, * Deterioration due to an acute or superimposed condition requiring therapy other than diuretics * Symptomatic ventricular tachycardia, * Severe concomitant primary hepatic disease, * Severe pulmonary disease, * Any other concomitant life-threatening disease, * CVA in the preceding 6 months, * Hypotension, * Participated in another clinical trial within 30 days, * Acute contrast nephropathy, * Admitted for heart transplant surgery or have had a heart transplant.

Design outcomes

Primary

Measure	Time frame
Change in urine volume from baseline	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026