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



Status:Terminated
Conditions:Renal Impairment / Chronic Kidney Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2009
End Date:January 2010

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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


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
We found this trial at
28
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