Clinical trial NCT00745316: Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral Tonapofylline in Patients With Heart Failure and Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Renal Insufficiency
Heart Failure
Keywords: Heart Failure
Renal Insufficiency
Congestive Heart Failure
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine the safety and tolerability of tonapofylline (BG9928) when given at different doses to patients with heart failure and renal insufficiency.

This study will also explore:

* Disease related quality-of-life
* Exercise capacity
* Renal function
* Concomitant medications


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosis of heart failure requiring hospitalization \>1 and ≤12 months prior to screening
* NYHA Class III or IV at the time of screening
* Renal insufficiency as defined by eGFR ≥20 and ≤70 mL/min/1.73 m2
* Negative pregnancy test

Exclusion Criteria:

* History of an allergic reaction to any xanthine-containing compound.
* History of seizure
* History of stroke
* Serious systemic infection
* Sustained systolic blood pressure \>170 or \<90 mmHg
* Myocardial infarction within 30 days of Day 1
* Hemodynamically destabilizing arrhythmia within 30 days of Day 1
* Uncorrected hemodynamically significant primary valvular disease
* Known obstructive or restrictive cardiomyopathy
* Cardiac surgery within 60 days prior to Day 1
* Likely to undergo cardiac transplantation, device implantation, or other cardiac surgery within next three months
* Evidence of malignancy within 6 months prior to Day 1.
* Participation in any other investigational study of drugs or devices within 30 days prior to Day 1.
* Receiving aminophylline, theophylline, pentoxifylline, dyphylline or adenosine
* Presence of any clinically significant condition that might interfere with optimal safe participation in this study

Primary outcomes:
measure: To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency.
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Bridgeport
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Owensboro
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Lincoln
country: United States
state: Nebraska
city: Bronx
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Lancaster
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Roanoke
country: United States
state: Virginia
city: Beloit
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: