Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency (TRIDENT-1)

September 4, 2023 updated by: Biogen

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

The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal, Argentina, C1437JCP
    • BUE
      • Buenos Aires, BUE, Argentina, B1605DSX
      • Buenos Aires, BUE, Argentina, B1722COV
    • CBA
      • Capital Federal, CBA, Argentina, C1280AEB
    • COR
      • Corrientes, COR, Argentina, W3400AMZ
    • CRD
      • Cordoba, CRD, Argentina, X5004CDT
      • Villa Cabrera, CRD, Argentina, X5009BSN
    • SFE
      • Santa Fe, SFE, Argentina, 3000
      • Santa Fe, SFE, Argentina, S3000FUJ
    • SLS
      • San Luis, SLS, Argentina, D5702JRS
    • TUC
      • Tucuman, TUC, Argentina, 4000
  • Australia
      • Canberra, Australia, ACT 2605
      • Dandenong, Australia, 3175
      • Melbourne, Australia, 3004
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
      • Liverpool, New South Wales, Australia, 2170
  • Brazil
      • Campo Grande, Brazil, 79080-190
      • Curitiba, Brazil, 80010-030
      • Porto Alegre, Brazil, 90620-001
      • Porto Alegre, Brazil, CEP 90350-200
      • Recife, Brazil, 50100-010
    • CE
      • Fortaleza, CE, Brazil, 60864-190
    • RS
      • Porto Alegre, RS, Brazil, 90110-270
    • SE
      • Aracaju, SE, Brazil, 49015-400
    • SP
      • Santo Andre, SP, Brazil, 09190-610
      • Sao Jose do Rio Preto, SP, Brazil, 15015-210
  • Bulgaria
      • Pazardjik, Bulgaria, 4400
      • Pleven, Bulgaria, 5800
      • Sofia, Bulgaria, 1606
      • Sofia, Bulgaria, 1527
      • Sofia, Bulgaria, 1202
      • Sofia, Bulgaria, 1309
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
  • Czechia
      • Kolin, Czechia, 280 20
      • Uherske Hradiste, Czechia, 686 68
  • Finland
      • Hus, Finland, 29
      • Lahti, Finland, 15850
      • Oulu, Finland, 90220
      • Seinäjoki, Finland, 60220
      • Turku, Finland, 20520
  • France
      • Albi, France, 81000
      • Antony cedex, France, 92 92166
      • Caen, France, 14033
      • Cholet Cedex, France, 49 49325
      • Paris cedex 13, France, 75 75651
      • Poitiers, France, 86 86021
      • Pontoise, France, 95300
      • Strasbourg Cedex, France, 67091
      • Toulouse Cedex 9, France, 31059
      • Tourcoinq, France, 59208
  • Germany
      • Bad Nauheim, Germany, HE 61231
      • Berlin, Germany, BE 12559
      • Berlin, Germany, BE 13353
      • Bochum, Germany, NW 44791
      • Essen, Germany, NW 45138
      • Frankfurt, Germany, HE 60590
      • Göttingen, Germany, NI 37075
      • Leipzig, Germany, 4289
      • Regensburg, Germany, BY 93042
      • Wuppertal, Germany, NW 42117
    • HE
      • Frankfurt, HE, Germany, 60488
  • India
      • Bangalore, India, 560034
      • Bikaner, India, 334003
      • Chennai, India, 600037
      • Delhi, India, 110055
      • Indore, India, 452018
      • Thrissur, India, 680002
    • Delhi
      • New Delhi, Delhi, India, 110060
    • Karna
      • Bangalore, Karna, India, 562158
    • Mahara
      • Pune, Mahara, India, 411004
  • Israel
      • Ashkelon, Israel, 78306
      • Beer Yaakov, Israel, 70300
      • Haifa, Israel, 31096
      • Holon, Israel, 58100
      • Jerusalem, Israel, 91120
      • Jerusalem, Israel, 91031
      • Jerusalem, Israel, 91240
      • Kfar Saba, Israel, 44281
      • Nahariya, Israel, 22100
      • Nazareth, Israel, 16000
      • Petach Tikva, Israel, 49100
      • Safed, Israel, 13100
      • Tel Aviv, Israel, 64239
  • Italy
      • Mantova, Italy, 46100
      • Milano, Italy, 20162
      • Pavia, Italy, PV 27100
  • Netherlands
      • Den Haag, Netherlands, 2512 VA
      • Maastricht, Netherlands, 6229 HX
      • Zwolle, Netherlands, 8011 JW
  • Poland
      • Koscierzyna, Poland, 83-400
      • Olsztyn, Poland, 10-045
      • Slupsk, Poland, 76-200
      • Tarnow, Poland, 33-100
      • Warszawa, Poland, 00-909
      • Warszawa, Poland, 04-628
      • Wroclaw, Poland, 51-124
      • Wroclaw, Poland, 50-981
  • Romania
      • Bacau, Romania, 600114
      • Bucuresti, Romania, 21659
      • Bucuresti, Romania, 22328
      • Bucuresti, Romania, 20125
  • Russian Federation
      • Barnaul, Russian Federation, 656099
      • Kemerovo, Russian Federation, 650002
      • Krasnoyarsk, Russian Federation, 660062
      • Moscow, Russian Federation, 123182
      • Moscow, Russian Federation, 125101
      • Moscow, Russian Federation, 127473
      • Moscow, Russian Federation, 127644
      • Moscow, Russian Federation, 113093
      • Novosibirsk, Russian Federation, 630075
      • Novosibirsk, Russian Federation, 630008
      • Novosibirsk, Russian Federation, 630090
      • Saratov, Russian Federation, 410028
      • St-Petersburg, Russian Federation, 198205
      • St-Petersburg, Russian Federation, 199106
      • St. Petersburg, Russian Federation, 192242
      • St. Petersburg, Russian Federation, 193318
      • Tomsk, Russian Federation, 634012
  • Sweden
      • Göteborg, Sweden, 413 45
      • Lidköping, Sweden, 53185
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
      • Mobile, Alabama, United States, 36608
    • Arkansas
      • Fort Smith, Arkansas, United States, 72917
    • California
      • Beverly Hills, California, United States, 90210
      • Chula Vista, California, United States, 91911
      • Mission Viejo, California, United States, 92691
      • Monterey Park, California, United States, 91754
      • Oceanside, California, United States, 92056
      • Redondo Beach, California, United States, 90277
      • San Diego, California, United States, 92103
      • Sylmar, California, United States, 91342
      • Torrance, California, United States, 90502
      • Yuba City, California, United States, 95991
    • Connecticut
      • Hartford, Connecticut, United States, 06102
    • Florida
      • Jacksonville, Florida, United States, 32216
      • Sarasota, Florida, United States, 34239
      • Tampa, Florida, United States, 33613
    • Illinois
      • Lombard, Illinois, United States, 60148
    • Indiana
      • Indianapolis, Indiana, United States, 46202
      • Muncie, Indiana, United States, 47303
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Kansas City, Kansas, United States, 64132
      • Wichita, Kansas, United States, 67220
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
      • Boston, Massachusetts, United States, 02114
      • Hyannis, Massachusetts, United States, 02601
      • Springfield, Massachusetts, United States, 01107
      • West Springfield, Massachusetts, United States, 01089
    • Michigan
      • Traverse City, Michigan, United States, 49684
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
    • Missouri
      • Kansas City, Missouri, United States, 64132
      • Lee's Summit, Missouri, United States, 64063
      • Saint Louis, Missouri, United States, 63128
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
    • New York
      • Bronx, New York, United States, 10461
      • Johnson City, New York, United States, 13790
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10021
      • Stony Brook, New York, United States, 11794
    • North Carolina
      • Concord, North Carolina, United States, 28025
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43210
      • Franklin, Ohio, United States, 45005
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
      • Oklahoma City, Oklahoma, United States, 73120
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
      • Danville, Pennsylvania, United States, 17822
      • Doylestown, Pennsylvania, United States, 18901
      • Lancaster, Pennsylvania, United States, 17603
      • Philadelphia, Pennsylvania, United States, 19140
    • Rhode Island
      • Providence, Rhode Island, United States, 02908
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
    • Tennessee
      • Nashville, Tennessee, United States, 37208
      • Oak Ridge, Tennessee, United States, 37830
      • Tullahoma, Tennessee, United States, 37388
    • Texas
      • Dallas, Texas, United States, 75216
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78215
      • Whitney, Texas, United States, 76692
    • Virginia
      • Danville, Virginia, United States, 24541
    • Washington
      • Olympia, Washington, United States, 98506
      • Tacoma, Washington, United States, 98405
    • West Virginia
      • Charleston, West Virginia, United States, 25304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 4
Placebo
Drug: Placebo
IV
Experimental: 1
.03 mg/kg
Drug: tonapofylline
IV
Other Names:
  • Adentri
  • BG9928
Experimental: 2
.15 mg/kg
Drug: tonapofylline
IV
Other Names:
  • Adentri
  • BG9928
Experimental: 3
.3 mg/kg
Drug: tonapofylline
IV
Other Names:
  • Adentri
  • BG9928

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
0-60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2008

Primary Completion (Actual)

October 30, 2009

Study Completion (Actual)

December 31, 2009

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimated)

July 3, 2008

Study Record Updates

Last Update Posted (Actual)

September 11, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160HF301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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