Study Stopped
Company Decision
Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency
POSEIDON
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
1 other identifier
interventional
34
1 country
30
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2009
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedSeptember 11, 2023
September 1, 2023
11 months
September 2, 2008
September 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency.
16 Weeks
Study Arms (6)
1
EXPERIMENTALoral Dose 1
2
EXPERIMENTALoral Dose 2
3
EXPERIMENTALoral Dose 3
4
EXPERIMENTALoral Dose 4
5
EXPERIMENTALoral Dose 5
6
PLACEBO COMPARATORPlacebo - 2 capsules bid
Interventions
Oral Tonapofylline - 2 capsules bid
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (30)
Unknown Facility
Huntsville, Alabama, 35801, United States
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Beverly Hills, California, 90210, United States
Unknown Facility
San Diego, California, 92103, United States
Unknown Facility
Denver, Colorado, 80218, United States
Unknown Facility
Bridgeport, Connecticut, 06606, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Melbourne, Florida, 32901, United States
Unknown Facility
Ormond Beach, Florida, 32174, United States
Unknown Facility
Chicago, Illinois, 60612, United States
Unknown Facility
Maywood, Illinois, 60153, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Owensboro, Kentucky, 42303, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Boston, Massachusetts, 02115, United States
Unknown Facility
Minneapolis, Minnesota, 55415, United States
Unknown Facility
Lincoln, Nebraska, 68506, United States
Unknown Facility
The Bronx, New York, 10461, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45267, United States
Unknown Facility
Oklahoma City, Oklahoma, 73120, United States
Unknown Facility
Lancaster, Pennsylvania, 17602, United States
Unknown Facility
Germantown, Tennessee, 38138, United States
Unknown Facility
Roanoke, Virginia, 24014, United States
Unknown Facility
Beloit, Wisconsin, 53511, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2008
First Posted
September 3, 2008
Study Start
February 1, 2009
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
September 11, 2023
Record last verified: 2023-09