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

Study Overview
=================
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

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

Conditions
-----------------
Renal Insufficiency, Heart Failure

Intervention / Treatment
-----------------
* Drug: Tonapofylline
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>oral Dose 1 | Drug: Tonapofylline<br>* Oral Tonapofylline - 2 capsules bid<br>* Other names: BG9928; Selective Adenosine A1 Receptor Antagonist;|
| Experimental: 2<br>oral Dose 2 | Drug: Tonapofylline<br>* Oral Tonapofylline - 2 capsules bid<br>* Other names: BG9928; Selective Adenosine A1 Receptor Antagonist;|
| Experimental: 3<br>oral Dose 3 | Drug: Tonapofylline<br>* Oral Tonapofylline - 2 capsules bid<br>* Other names: BG9928; Selective Adenosine A1 Receptor Antagonist;|
| Experimental: 4<br>oral Dose 4 | Drug: Tonapofylline<br>* Oral Tonapofylline - 2 capsules bid<br>* Other names: BG9928; Selective Adenosine A1 Receptor Antagonist;|
| Experimental: 5<br>oral Dose 5 | Drug: Tonapofylline<br>* Oral Tonapofylline - 2 capsules bid<br>* Other names: BG9928; Selective Adenosine A1 Receptor Antagonist;|
| Placebo Comparator: 6<br>Placebo - 2 capsules bid | Drug: Placebo<br>* Oral placebo - 2 capsules bid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of BG9928 administered to subjects with heart failure and renal insufficiency. |  | 16 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Renal Insufficiency, Congestive Heart Failure