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

Biogen

Status and phase: Terminated; Phase 2

Conditions: Heart Failure; Renal Insufficiency

Treatments: Drug: Tonapofylline; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00745316

161HF201

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

oral Dose 1

Treatment:

Drug: Tonapofylline

2

Experimental group

Description:

oral Dose 2

Treatment:

Drug: Tonapofylline

3

Experimental group

Description:

oral Dose 3

Treatment:

Drug: Tonapofylline

4

Experimental group

Description:

oral Dose 4

Treatment:

Drug: Tonapofylline

5

Experimental group

Description:

oral Dose 5

Treatment:

Drug: Tonapofylline

6

Placebo Comparator group

Description:

Placebo - 2 capsules bid

Treatment:

Drug: Placebo