Back to resultsStudy to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency (TRIDENT-1)
Primary Purpose
Renal Insufficiency, Congestive Heart Failure
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tonapofylline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency focused on measuring renal insufficiency, diuretic, congestive heart failure, acute decompensated heart failure
Eligibility Criteria
Inclusion Criteria:
- Previous diagnosis of heart failure.
- Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Exclusion Criteria:
- History of an allergic reaction to any xanthine-containing substance.
- History of seizure
- History of stroke
- Myocardial infarction
- Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.
- Serious systemic infection
- Major surgical procedures within 30 days
- Acute coronary syndrome
- Cardiogenic shock
- Baseline body weight >150 kg
- Participation in any other investigational study of drugs or devices within 30 days prior to Screening
- Nursing mothers, pregnant women, or women planning on becoming pregnant during the study
- Presence of any clinically significant condition that might interfere with optimal safe participation in this study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
.03 mg/kg
.15 mg/kg
.3 mg/kg
Placebo
Outcomes
Primary Outcome Measures
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00709865
Brief Title
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
Acronym
TRIDENT-1
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Tolerability of Intravenous Tonapofylline in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 31, 2008 (Actual)
Primary Completion Date
October 30, 2009 (Actual)
Study Completion Date
December 31, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Congestive Heart Failure
Keywords
renal insufficiency, diuretic, congestive heart failure, acute decompensated heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
.03 mg/kg
Arm Title
2
Arm Type
Experimental
Arm Description
.15 mg/kg
Arm Title
3
Arm Type
Experimental
Arm Description
.3 mg/kg
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
tonapofylline
Other Intervention Name(s)
Adentri, BG9928
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV
Primary Outcome Measure Information:
Title
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
Time Frame
0-60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous diagnosis of heart failure.
Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Exclusion Criteria:
History of an allergic reaction to any xanthine-containing substance.
History of seizure
History of stroke
Myocardial infarction
Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.
Serious systemic infection
Major surgical procedures within 30 days
Acute coronary syndrome
Cardiogenic shock
Baseline body weight >150 kg
Participation in any other investigational study of drugs or devices within 30 days prior to Screening
Nursing mothers, pregnant women, or women planning on becoming pregnant during the study
Presence of any clinically significant condition that might interfere with optimal safe participation in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
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United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
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United States
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Fort Smith
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Arkansas
ZIP/Postal Code
72917
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United States
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Beverly Hills
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California
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90210
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United States
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Chula Vista
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California
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91911
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United States
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Mission Viejo
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California
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92691
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United States
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Monterey Park
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California
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91754
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United States
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Oceanside
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California
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92056
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United States
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Redondo Beach
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California
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90277
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United States
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San Diego
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California
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92103
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United States
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Sylmar
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91342
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United States
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Torrance
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California
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90502
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United States
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Yuba City
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California
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95991
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United States
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Hartford
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Connecticut
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06102
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United States
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Jacksonville
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Florida
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32216
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United States
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Sarasota
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Florida
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34239
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United States
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Tampa
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Florida
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33613
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United States
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Lombard
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Illinois
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60148
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United States
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Indianapolis
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Indiana
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46202
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Muncie
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Iowa City
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Iowa
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52242
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Kansas City
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Kansas
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64132
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Wichita
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67220
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21201
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Ayer
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01432
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02114
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Hyannis
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02601
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Springfield
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Massachusetts
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01107
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West Springfield
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01089
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Traverse City
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49684
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Minneapolis
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55404
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64132
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64063
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63128
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New York
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13790
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Mineola
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New York
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11501
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New York
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10021
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New York
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11794
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28025
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45267
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29118
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37830
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BUE
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B1605DSX
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Argentina
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B1722COV
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Argentina
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CBA
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C1280AEB
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Argentina
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Corrientes
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COR
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W3400AMZ
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Argentina
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Cordoba
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CRD
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X5004CDT
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Argentina
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Villa Cabrera
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CRD
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X5009BSN
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Argentina
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Santa Fe
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SFE
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3000
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Argentina
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Santa Fe
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SFE
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S3000FUJ
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Argentina
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San Luis
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SLS
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D5702JRS
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Argentina
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Tucuman
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TUC
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4000
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Argentina
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C1437JCP
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Argentina
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Darlinghurst
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2010
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Australia
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Liverpool
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New South Wales
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2170
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Australia
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ACT 2605
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Australia
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Dandenong
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3175
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Melbourne
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3004
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CE
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RS
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90110-270
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Brazil
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Aracaju
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SE
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49015-400
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Brazil
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Santo Andre
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SP
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09190-610
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Brazil
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Sao Jose do Rio Preto
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SP
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Brazil
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Campo Grande
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79080-190
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Brazil
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Curitiba
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80010-030
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Brazil
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Porto Alegre
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90620-001
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Brazil
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Porto Alegre
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CEP 90350-200
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Brazil
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Recife
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50100-010
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Brazil
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Pazardjik
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4400
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Bulgaria
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Pleven
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5800
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Bulgaria
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Sofia
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1202
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Bulgaria
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Sofia
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1309
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Bulgaria
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Sofia
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1527
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Bulgaria
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Sofia
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Saint John
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New Brunswick
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Kolin
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280 20
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Czechia
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Uherske Hradiste
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686 68
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Czechia
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Hus
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29
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Finland
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Lahti
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15850
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Finland
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Oulu
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90220
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Finland
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Seinäjoki
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60220
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Finland
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Turku
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20520
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Finland
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Albi
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81000
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France
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Antony cedex
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92 92166
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France
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Caen
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14033
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France
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Cholet Cedex
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49 49325
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France
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Paris cedex 13
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75 75651
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France
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Poitiers
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86 86021
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France
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Pontoise
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95300
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France
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Strasbourg Cedex
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67091
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France
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Toulouse Cedex 9
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31059
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France
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Tourcoinq
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59208
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France
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Frankfurt
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HE
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60488
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Germany
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Bad Nauheim
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HE 61231
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Germany
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Berlin
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BE 12559
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Germany
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Berlin
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BE 13353
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Germany
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Bochum
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NW 44791
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Germany
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Essen
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NW 45138
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Germany
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Frankfurt
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HE 60590
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Germany
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Göttingen
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NI 37075
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Germany
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Leipzig
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4289
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Germany
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Regensburg
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BY 93042
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Germany
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Wuppertal
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NW 42117
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Germany
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Delhi
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India
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Karna
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562158
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India
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Pune
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Mahara
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411004
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India
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Bangalore
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560034
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India
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Bikaner
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334003
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India
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Thrissur
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Ashkelon
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Beer Yaakov
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Israel
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Haifa
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31096
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Israel
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Holon
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58100
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Israel
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Jerusalem
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91031
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Israel
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Jerusalem
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91120
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Israel
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Jerusalem
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91240
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Israel
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Kfar Saba
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Israel
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Nahariya
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22100
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Israel
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Nazareth
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16000
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Israel
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Petach Tikva
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Israel
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Safed
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13100
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Israel
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Tel Aviv
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64239
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Israel
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Mantova
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46100
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Italy
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Milano
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20162
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Italy
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Pavia
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PV 27100
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Italy
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Den Haag
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2512 VA
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Netherlands
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Maastricht
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6229 HX
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Netherlands
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Zwolle
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8011 JW
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Netherlands
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Koscierzyna
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83-400
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Poland
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Olsztyn
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10-045
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Poland
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Slupsk
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76-200
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Poland
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Tarnow
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33-100
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Poland
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Warszawa
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00-909
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Poland
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Warszawa
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04-628
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Poland
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Wroclaw
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50-981
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Poland
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Wroclaw
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51-124
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Poland
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Bacau
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600114
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Romania
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20125
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Romania
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Bucuresti
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21659
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Romania
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Bucuresti
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22328
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Romania
City
Barnaul
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656099
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Russian Federation
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Kemerovo
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650002
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Russian Federation
City
Krasnoyarsk
ZIP/Postal Code
660062
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Russian Federation
City
Moscow
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113093
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Russian Federation
City
Moscow
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123182
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Russian Federation
City
Moscow
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125101
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Russian Federation
City
Moscow
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127473
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Russian Federation
City
Moscow
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127644
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Russian Federation
City
Novosibirsk
ZIP/Postal Code
630008
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Russian Federation
City
Novosibirsk
ZIP/Postal Code
630075
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Russian Federation
City
Novosibirsk
ZIP/Postal Code
630090
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Russian Federation
City
Saratov
ZIP/Postal Code
410028
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Russian Federation
City
St-Petersburg
ZIP/Postal Code
198205
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Russian Federation
City
St-Petersburg
ZIP/Postal Code
199106
Country
Russian Federation
City
St. Petersburg
ZIP/Postal Code
192242
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Russian Federation
City
St. Petersburg
ZIP/Postal Code
193318
Country
Russian Federation
City
Tomsk
ZIP/Postal Code
634012
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Russian Federation
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Lidköping
ZIP/Postal Code
53185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
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