Renal InsufficiencyPhase 3TRIDENT-1NCT00709865
Study to Assess the Safety and Tolerability of IV Tonapofylline in Subjects With Acute Decompensated Heart Failure (ADHF) and Renal Insufficiency
A Phase 3 study testing tonapofylline in people with Renal Insufficiency and Congestive Heart Failure, run by Biogen at 189 sites in 18 countries.
Trial summary
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Insufficiency, Congestive Heart Failure
- What is being tested?
- tonapofylline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 189 sitesin 18 countries
- Study dates
- 31 Jul 2008to 31 Dec 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of heart failure.
- Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
189 sites in 18 countries.
189 sites in 18 countries
United States68 sites
Study site
Ayer, Massachusetts, 01432
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Baltimore, Maryland, 21201
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Beverly Hills, California, 90210
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Boston, Massachusetts, 02114
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Camp Hill, Pennsylvania, 17011
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Charleston, West Virginia, 25304
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Chula Vista, California, 91911
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Cincinnati, Ohio, 45267
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Cleveland, Ohio, 44195
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Columbus, Ohio, 43210
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Concord, North Carolina, 28025
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Dallas, Texas, 75216
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Danville, Pennsylvania, 17822
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Danville, Virginia, 24541
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Doylestown, Pennsylvania, 18901
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Fort Smith, Arkansas, 72917
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Franklin, Ohio, 45005
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Hartford, Connecticut, 06102
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Houston, Texas, 77030
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Huntsville, Alabama, 35801
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Hyannis, Massachusetts, 02601
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Indianapolis, Indiana, 46202
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32216
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Johnson City, New York, 13790
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Kansas City, Kansas, 64132
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Kansas City, Missouri, 64132
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Lancaster, Pennsylvania, 17603
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Lee's Summit, Missouri, 64063
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Lombard, Illinois, 60148
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Mineola, New York, 11501
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Minneapolis, Minnesota, 55404
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Mission Viejo, California, 92691
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Mobile, Alabama, 36608
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Monterey Park, California, 91754
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Muncie, Indiana, 47303
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Nashville, Tennessee, 37208
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New York, New York, 10021
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Oak Ridge, Tennessee, 37830
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Oceanside, California, 92056
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Oklahoma City, Oklahoma, 73109
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Oklahoma City, Oklahoma, 73120
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Olympia, Washington, 98506
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Omaha, Nebraska, 68131
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Orangeburg, South Carolina, 29118
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Philadelphia, Pennsylvania, 19140
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Portland, Oregon, 97213
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Providence, Rhode Island, 02908
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Redondo Beach, California, 90277
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Ridgewood, New Jersey, 07450
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San Antonio, Texas, 78215
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San Diego, California, 92103
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Sarasota, Florida, 34239
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Springfield, Massachusetts, 01107
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St Louis, Missouri, 63128
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Stony Brook, New York, 11794
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Sylmar, California, 91342
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Tacoma, Washington, 98405
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Tampa, Florida, 33613
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The Bronx, New York, 10461
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Torrance, California, 90502
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Traverse City, Michigan, 49684
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Tullahoma, Tennessee, 37388
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Tulsa, Oklahoma, 74104
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West Springfield, Massachusetts, 01089
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Whitney, Texas, 76692
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Wichita, Kansas, 67220
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Yuba City, California, 95991
Russia17 sites
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Barnaul, 656099
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Kemerovo, 650002
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Krasnoyarsk, 660062
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Moscow, 113093
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Moscow, 123182
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Moscow, 125101
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Moscow, 127473
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Moscow, 127644
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Novosibirsk, 630008
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Novosibirsk, 630075
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Novosibirsk, 630090
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Saint Petersburg, 192242
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Saint Petersburg, 193318
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Saint Petersburg, 198205
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Saint Petersburg, 199106
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Saratov, 410028
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Tomsk, 634012
Israel13 sites
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Ashkelon, 78306
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Beer Yaakov, 70300
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Haifa, 31096
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Holon, 58100
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Jerusalem, 91031
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Jerusalem, 91120
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Jerusalem, 91240
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Kfar Saba, 44281
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Nahariya, 22100
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Nazareth, 16000
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Petah Tikva, 49100
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Safed, 13100
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Tel Aviv, 64239
Argentina11 sites
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Buenos Aires, BUE, B1605DSX
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Buenos Aires, BUE, B1722COV
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Capital Federal, CBA, C1280AEB
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Capital Federal, C1437JCP
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Córdoba, CRD, X5004CDT
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Corrientes, COR, W3400AMZ
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San Luis, SLS, D5702JRS
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San Miguel de Tucumán, TUC, 4000
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Santa Fe, SFE, 3000
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Santa Fe, SFE, S3000FUJ
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Villa Cabrera, CRD, X5009BSN
Germany11 sites
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Bad Nauheim, HE 61231
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Berlin, BE 12559
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Berlin, BE 13353
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Bochum, NW 44791
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Essen, NW 45138
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Frankfurt, HE 60590
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Frankfurt am Main, Hesse, 60488
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Göttingen, NI 37075
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Leipzig, 4289
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Regensburg, BY 93042
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Wuppertal, NW 42117
Brazil10 sites
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Aracaju, Sergipe, 49015-400
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Campo Grande, 79080-190
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Curitiba, 80010-030
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Fortaleza, Ceará, 60864-190
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Porto Alegre, Rio Grande do Sul, 90110-270
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Porto Alegre, 90620-001
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Porto Alegre, CEP 90350-200
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Recife, 50100-010
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Santo André, São Paulo, 09190-610
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São José do Rio Preto, São Paulo, 15015-210
France10 sites
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Albi, 81000
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Antony, 92 92166
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Caen, 14033
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Cholet, 49 49325
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Paris, 75 75651
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Poitiers, 86 86021
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Pontoise, 95300
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Strasbourg, 67091
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Toulouse, 31059
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Tourcoinq, 59208
India9 sites
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Bangalore, Karna, 562158
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Bangalore, 560034
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Bikaner, 334003
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Chennai, 600037
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Delhi, 110055
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Indore, 452018
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New Delhi, National Capital Territory of Delhi, 110060
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Pune, Mahara, 411004
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Thrissur, 680002
Poland8 sites
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Kościerzyna, 83-400
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Olsztyn, 10-045
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Słupsk, 76-200
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Tarnów, 33-100
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Warsaw, 00-909
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Warsaw, 04-628
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Wroclaw, 50-981
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Wroclaw, 51-124
Bulgaria6 sites
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Pazardzhik, 4400
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Pleven, 5800
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Sofia, 1202
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Sofia, 1309
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Sofia, 1527
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Sofia, 1606
Australia5 sites
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Canberra, ACT 2605
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Dandenong, 3175
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Darlinghurst, New South Wales, 2010
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Liverpool, New South Wales, 2170
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Melbourne, 3004
Finland5 sites
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Hus, 29
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Lahti, 15850
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Oulu, 90220
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Seinäjoki, 60220
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Turku, 20520
Romania4 sites
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Bacau, 600114
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Bucharest, 20125
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Bucharest, 21659
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Bucharest, 22328
Italy3 sites
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Mantua, 46100
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Milan, 20162
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Pavia, PV 27100
Netherlands3 sites
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Maastricht, 6229 HX
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The Hague, 2512 VA
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Zwolle, 8011 JW
Canada2 sites
Study site
Saint John, New Brunswick, E2L 4L2
Study site
Vancouver, British Columbia, V5Z 1M9
About this study
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
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
- Conditions
- Renal Insufficiency, Congestive Heart Failure
- Being tested
- tonapofylline, Placebo
- Keywords
- renal insufficiency, diuretic, congestive heart failure, acute decompensated heart failure
- Medical subject headings
- Renal Insufficiency, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tonapofyllineDrug
Also called Adentri, BG9928
IV
PlaceboDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | .03 mg/kg Receives: Drug: tonapofylline |
| 2 | Experimental | .15 mg/kg Receives: Drug: tonapofylline |
| 3 | Experimental | .3 mg/kg Receives: Drug: tonapofylline |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
Measured: 0-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study start31 Jul 2008
- Primary completion30 Oct 2009
- Study completion31 Dec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709865
- Sponsor's protocol ID
- 160HF301
- Acronym
- TRIDENT-1
- Status last verified
- Sep 2023
- First submitted
- 1 Jul 2008
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00709865
- Acronym / sponsor ID
- TRIDENT-1 / 160HF301
- Conditions
- Renal Insufficiency, Congestive Heart Failure
- Keywords
- renal insufficiency, diuretic, congestive heart failure, acute decompensated heart failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2008 (actual)
- Primary completion
- 30 Oct 2009 (actual)
- Study completion
- 31 Dec 2009 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tonapofylline.03 mg/kg |
| 2 | Experimental | Drug: tonapofylline.15 mg/kg |
| 3 | Experimental | Drug: tonapofylline.3 mg/kg |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous diagnosis of heart failure.
- Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tonapofyllineAlso: Adentri, BG9928IV | Drug | 1, 2, 3 |
| PlaceboIV | Drug | 4 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
189 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tonapofylline in people with Renal Insufficiency and Congestive Heart Failure, run by Biogen at 189 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 189 sites in United States, Russia, Israel, Argentina, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.