Renal InsufficiencyPhase 2POSEIDONNCT00745316
Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency
A Phase 2 study testing Tonapofylline in people with Renal Insufficiency and Heart Failure, run by Biogen at 30 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Heart Failure
- What is being tested?
- Tonapofylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 30 sitesUnited States
- Study dates
- Feb 2009to Jan 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Study site
Baltimore, Maryland, 21201
Study site
Beloit, Wisconsin, 53511
Study site
Beverly Hills, California, 90210
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02115
Study site
Bridgeport, Connecticut, 06606
Study site
Chicago, Illinois, 60612
Study site
Cincinnati, Ohio, 45219
Study site
Cincinnati, Ohio, 45267
Study site
Denver, Colorado, 80218
Study site
Germantown, Tennessee, 38138
Study site
Huntsville, Alabama, 35801
Study site
Indianapolis, Indiana, 46260
Study site
Iowa City, Iowa, 52242
Study site
Jacksonville, Florida, 32209
Study site
Lancaster, Pennsylvania, 17602
Study site
Lincoln, Nebraska, 68506
Study site
Madison, Wisconsin, 53792
Study site
Maywood, Illinois, 60153
Study site
Melbourne, Florida, 32901
Study site
Minneapolis, Minnesota, 55415
Study site
Mobile, Alabama, 36608
Study site
Oklahoma City, Oklahoma, 73120
Study site
Ormond Beach, Florida, 32174
Study site
Owensboro, Kentucky, 42303
Study site
Roanoke, Virginia, 24014
Study site
San Diego, California, 92103
Study site
Scottsdale, Arizona, 85251
Study site
The Bronx, New York, 10461
Study site
Tucson, Arizona, 85710
About this study
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
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
- Conditions
- Renal Insufficiency, Heart Failure
- Being tested
- Tonapofylline, Placebo
- Keywords
- Heart Failure, Renal Insufficiency, Congestive Heart Failure
- Medical subject headings
- Renal Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TonapofyllineDrug
Also called BG9928; Selective Adenosine A1 Receptor Antagonist
Oral Tonapofylline - 2 capsules bid
PlaceboDrug
Oral placebo - 2 capsules bid
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | oral Dose 1 Receives: Drug: Tonapofylline |
| 2 | Experimental | oral Dose 2 Receives: Drug: Tonapofylline |
| 3 | Experimental | oral Dose 3 Receives: Drug: Tonapofylline |
| 4 | Experimental | oral Dose 4 Receives: Drug: Tonapofylline |
| 5 | Experimental | oral Dose 5 Receives: Drug: Tonapofylline |
| 6 | Placebo comparator | Placebo - 2 capsules bid Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency.
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Company Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745316
- Sponsor's protocol ID
- 161HF201
- Acronym
- POSEIDON
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2008
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00745316
- Acronym / sponsor ID
- POSEIDON / 161HF201
- Conditions
- Renal Insufficiency, Heart Failure
- Keywords
- Heart Failure, Renal Insufficiency, Congestive Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company Decision
- Enrolment
- 34 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tonapofyllineoral Dose 1 |
| 2 | Experimental | Drug: Tonapofyllineoral Dose 2 |
| 3 | Experimental | Drug: Tonapofyllineoral Dose 3 |
| 4 | Experimental | Drug: Tonapofyllineoral Dose 4 |
| 5 | Experimental | Drug: Tonapofyllineoral Dose 5 |
| 6 | Placebo comparator | Drug: PlaceboPlacebo - 2 capsules bid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TonapofyllineAlso: BG9928; Selective Adenosine A1 Receptor AntagonistOral Tonapofylline - 2 capsules bid | Drug | 1, 2, 3, 4, 5 |
| PlaceboOral placebo - 2 capsules bid | Drug | 6 |
Primary outcome
To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency.
Time frame: 16 Weeks
Results and safety
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tonapofylline in people with Renal Insufficiency and Heart Failure, run by Biogen at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Company Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency. (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.