Oral Tonapofylline (BG9928) in Patients With Heart Failure and Renal Insufficiency

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745316

Acronym

POSEIDON

Enrollment

Registered

2008-09-03

Start date

2009-02-28

Completion date

2010-01-31

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Renal Insufficiency

Keywords

Heart Failure, Renal Insufficiency, Congestive Heart Failure

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

Interventions

DRUGTonapofylline

Oral Tonapofylline - 2 capsules bid

DRUGPlacebo

Oral placebo - 2 capsules bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency.	16 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026