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

Phase 2

Terminated

• Conditions: Renal Insufficiency; Heart Failure
• Interventions: Drug: Tonapofylline; Drug: Placebo

• Registration Number: NCT00745316
• Lead Sponsor: Biogen

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Study Start: 2009-02
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Disposition First Submitted: 2015-11-19
• Disposition First Submitted QC: 2016-01-07
• Disposition First Posted: 2016-02-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Tonapofylline	oral Dose 2
6	Placebo	Placebo - 2 capsules bid
3	Tonapofylline	oral Dose 3
4	Tonapofylline	oral Dose 4
1	Tonapofylline	oral Dose 1
5	Tonapofylline	oral Dose 5

Primary Outcome Measures

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