Status:
TERMINATED
Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency
Lead Sponsor:
Biogen
Conditions:
Renal Insufficiency
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00745316
Start Date
February 1 2009
End Date
January 1 2010
Last Update
September 11 2023
Active Locations (30)
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1
Huntsville, Alabama, United States, 35801
2
Mobile, Alabama, United States, 36608
3
Scottsdale, Arizona, United States, 85251
4
Tucson, Arizona, United States, 85710