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

Heart Failure Clinical Trial

— POSEIDON  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00745316
• Other study ID #: 161HF201
• Status: Terminated
• Phase: Phase 2
• Start date: February 2009
• Est. completion date: January 2010

Study information

• Verified date: September 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Renal Insufficiency

Intervention

Drug:
• Tonapofylline
Oral Tonapofylline - 2 capsules bid
• Placebo
Oral placebo - 2 capsules bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

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