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

This study has been terminated.
(Company Decision)
Sponsor:
Information provided by (Responsible Party):
Biogen
ClinicalTrials.gov Identifier:
NCT00745316
First received: September 2, 2008
Last updated: January 7, 2016
Last verified: January 2016
  Purpose

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

Condition Intervention Phase
Renal Insufficiency
Heart Failure
Drug: Tonapofylline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency. [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 34
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
oral Dose 1
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
Other Name: BG9928; Selective Adenosine A1 Receptor Antagonist
Experimental: 2
oral Dose 2
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
Other Name: BG9928; Selective Adenosine A1 Receptor Antagonist
Experimental: 3
oral Dose 3
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
Other Name: BG9928; Selective Adenosine A1 Receptor Antagonist
Experimental: 4
oral Dose 4
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
Other Name: BG9928; Selective Adenosine A1 Receptor Antagonist
Experimental: 5
oral Dose 5
Drug: Tonapofylline
Oral Tonapofylline - 2 capsules bid
Other Name: BG9928; Selective Adenosine A1 Receptor Antagonist
Placebo Comparator: 6
Placebo - 2 capsules bid
Drug: Placebo
Oral placebo - 2 capsules bid

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745316

  Show 30 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00745316     History of Changes
Other Study ID Numbers: 161HF201 
Study First Received: September 2, 2008
Last Updated: January 7, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen:
Heart Failure
Renal Insufficiency
Congestive Heart Failure

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Adenosine A1 Receptor Antagonists
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 29, 2016