KW-3902IV in the Treatment of Subjects with Worsening Renal Function and Heart Failure Requiring Intravenous Therapy. 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 - Reach UP (CKI-303)

Phase 1

• Conditions: Heart failure associated with worsening renal function requiring intravenous (IV) therapy; MedDRA version: 9.1 Level: HLGT Classification code 10007539 Term: Cardiac disorder signs and symptoms

• Registration Number: EUCTR2006-006843-29-IT
• Lead Sponsor: ovaCardia Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-01
• Study Completion: 2009-01-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 480

Inclusion Criteria

Able to provide written informed consent, or a legally authorized representative is able to provide written informed consent

Male or female 18 years of age or greater

Dyspnea at rest or with minimal exertion at randomization

Fluid overload as manifested by at least one of the following present at randomization:JVP >10 cm, OR Pulmonary rales ≥1/3 up the lung fields, not clearing with cough,OR≥2+ peripheral or pre-sacral edema

Estimated creatinine clearance (CrCl) between 20?60 mL/min usingthe Cockcroft-Gault equation (corrected for height in edematoussubjects ≥100 kg) based on a serum creatinine (SCr) value drawnwithin approximately 6 hours of randomization

Worsening renal function as manifested by one of the followingpresent at randomization:An increase in SCr of at least 25% or at least 0.3 mg/dL from the time of initial presentation for this hospitalization in patients hospitalized with heart failure requiring IV diuretic therapy, OR A documented increase in SCr over the preceding 30 days prior to randomization of at least 40% or at least 0.3 mg/dL in patients being admitted for heart failure requiring IV therapy (these patients must be randomized within 24 hours of admission)

Anticipated need for IV diuretic treatment for at least 48 hours after the start of study drug

BNP >500 pg/mL or NT-pro-BNP >2000 pg/mL

Systolic blood pressure ≥90 mmHg at randomization. Subjects with systolic blood pressure of 85-89 mmHg at randomization may be included if their usual systolic blood pressure measurements are consistently within 85-89 mmHg while clinically stable.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous exposure to KW-3902

Pregnant or breast feeding women.

3.Any administration of IV radiographic contrast within 14 days of

randomization or any procedures with IV radiographic contrast

Severe pulmonary disease

Significant stenotic mitral or aortic valvular disease

Heart transplant recipient or admitted for cardiac transplantation or

LVAD surgery

Any major surgery within 2 weeks prior to screening (cardiac or

non-cardiac)

Allergy to soybean oil or eggs

History of seizure (except febrile seizure)

Stroke within 2 years

History of brain tumor of any etiology

Brain surgery within 2 years

Encephalitis/meningitis within 2 years

History of penetrating head trauma

Closed head injury with loss of consciousness (LOC) over 30 minutes within 2 years

History of or at risk for alcohol withdrawal seizures

34.Advanced Alzheimer?s disease

35.Advanced multiple sclerosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified