Placebo-Controlled Randomized Study of KW-3902 for Subjects Hospitalized With Worsening Renal Function and Heart Failure Requiring IV Therapy

NCT00443690 | Completed Phase 3 DMC

• 3 other identifiers: CKI-3032007_805MK7418-303
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure, Congestive

Keywords

heart failure; diuretic; renal impairment; renal function

Outcome Measures

Primary Outcomes (2)

• Effect on heart failure signs and symptoms

  through day 7

• Effect on renal function

  through Day 7

Study Arms (2)

2

PLACEBO COMPARATOR

placebo control

Drug: Comparator: Placebo (unspecified)

1

EXPERIMENTAL

KW-3902IV

Drug: rolofylline

Interventions

rolofylline DRUG

rolofylline 30 mg IV QD; 3 days

Also known as: KW-3902IV, MK7418

1

Comparator: Placebo (unspecified) DRUG

rolofylline Pbo 30 mg IV QD; 3 days

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dyspnea at rest or with minimal exertion at randomization
• Fluid overload
• Estimated creatinine clearance (CrCl) between 20-60 mL/min
• Worsening renal function
• 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

You may not qualify if:

• IV radiographic contrast within 14 days
• IV vasodilators within 6 hours
• Serum potassium \<3.5 meq/L
• Ongoing or planned therapy for heart failure with mechanical circulatory or ventilatory support
• Ongoing or planned treatment with ultrafiltration, hemofiltration, or dialysis
• Rapidly progressive acute renal failure
• Evidence of acute tubular necrosis or post-obstructive nephropathy or other exogenous causes of acute kidney injury, unrelated to heart failure
• 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
• evidence of acute coronary syndrome in the 2 weeks prior
• Hgb \<8 g/dL, Hct \<25%, or active bleeding requiring transfusion
• Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy.
• Known hepatic impairment

Sponsors & Collaborators

• NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• Merck Sharp & Dohme LLC: collaborator

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency

Interventions

rolofylline

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Barry Massie, MD

  University of California San Francisco, USA

  STUDY CHAIR

• Christopher O'Connor, MD

  Duke University, USA

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 6, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 20, 2009

Record last verified: 2009-02