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

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 Overview

• Status: Terminated
• Conditions: Heart Failure; Renal Insufficiency
• Intervention / Treatment: Drug: Tonapofylline; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
    • Mobile, Alabama, United States, 36608
  • Arizona
    • Scottsdale, Arizona, United States, 85251
    • Tucson, Arizona, United States, 85710
  • California
    • Beverly Hills, California, United States, 90210
    • San Diego, California, United States, 92103
  • Colorado
    • Denver, Colorado, United States, 80218
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
  • Florida
    • Jacksonville, Florida, United States, 32209
    • Melbourne, Florida, United States, 32901
    • Ormond Beach, Florida, United States, 32174
  • Illinois
    • Chicago, Illinois, United States, 60612
    • Maywood, Illinois, United States, 60153
  • Indiana
    • Indianapolis, Indiana, United States, 46260
  • Iowa
    • Iowa City, Iowa, United States, 52242
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
  • Maryland
    • Baltimore, Maryland, United States, 21201
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
    • Boston, Massachusetts, United States, 02115
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
  • New York
    • Bronx, New York, United States, 10461
  • Ohio
    • Cincinnati, Ohio, United States, 45219
    • Cincinnati, Ohio, United States, 45267
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17602
  • Tennessee
    • Germantown, Tennessee, United States, 38138
  • Virginia
    • Roanoke, Virginia, United States, 24014
  • Wisconsin
    • Beloit, Wisconsin, United States, 53511
    • Madison, Wisconsin, United States, 53792

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; oral Dose 1	Drug: Tonapofylline; Oral Tonapofylline - 2 capsules bid; Other Names: BG9928; Selective Adenosine A1 Receptor Antagonist
Experimental: 2; oral Dose 2	Drug: Tonapofylline; Oral Tonapofylline - 2 capsules bid; Other Names: BG9928; Selective Adenosine A1 Receptor Antagonist
Experimental: 3; oral Dose 3	Drug: Tonapofylline; Oral Tonapofylline - 2 capsules bid; Other Names: BG9928; Selective Adenosine A1 Receptor Antagonist
Experimental: 4; oral Dose 4	Drug: Tonapofylline; Oral Tonapofylline - 2 capsules bid; Other Names: BG9928; Selective Adenosine A1 Receptor Antagonist
Experimental: 5; oral Dose 5	Drug: Tonapofylline; Oral Tonapofylline - 2 capsules bid; Other Names: BG9928; Selective Adenosine A1 Receptor Antagonist
Placebo Comparator: 6; Placebo - 2 capsules bid	Drug: Placebo; Oral placebo - 2 capsules bid

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: September 2, 2008
• First Submitted That Met QC Criteria: September 2, 2008
• First Posted (Estimated): September 3, 2008

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Renal Insufficiency; Congestive Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Renal Insufficiency; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Purinergic Antagonists; Purinergic Agents; Purinergic P1 Receptor Antagonists; Purinergic P1 Receptor Agonists; Purinergic Agonists; Adenosine; Adenosine A1 Receptor Antagonists
• Other Study ID Numbers: 161HF201