NCT00709865 (TRIDENT-1) is a Phase 3 clinical trial of tonapofylline in Renal Insufficiency, sponsored by Biogen.

Who is sponsoring NCT00709865?

NCT00709865 is sponsored by Biogen.

What drugs are being tested in NCT00709865?

Interventions in NCT00709865: tonapofylline, Placebo.

What condition does NCT00709865 study?

NCT00709865 studies Renal Insufficiency, Congestive Heart Failure.

Is NCT00709865 still recruiting?

NCT00709865 is currently completed. Last updated 11 September 2023.

Last reviewed 2023-09-11 · How we verify

NCT00709865: TRIDENT-1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 11 September 2023

What this trial tests

Phase 3 trial testing tonapofylline in Renal Insufficiency in 420 participants. Completed in 31 December 2009.

Timeline

31 July 2008

Primary endpoint
30 October 2009

31 December 2009

Quick facts

Lead sponsor	Biogen
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	420
Start date	31 July 2008
Primary completion	30 October 2009
Estimated completion	31 December 2009
Sites	189 locations across France, Italy, Finland, Netherlands, Russia, India, Sweden, Germany

Drugs / interventions tested

tonapofylline — full drug profile →
Placebo

Conditions studied

Renal Insufficiency — all drugs for Renal Insufficiency →
Congestive Heart Failure — all drugs for Congestive Heart Failure →

Sponsor

Biogen — full company profile →

Who can join

18 and older, any sex, with Renal Insufficiency or Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Adenosine receptors as drug targets--what are the challenges?
Chen JF, Eltzschig HK, Fredholm BB. · · 2013 · cited 678× · PMID 23535933 · DOI 10.1038/nrd3955
Adenosine A1 and A2A Receptors in the Brain: Current Research and Their Role in Neurodegeneration.
Stockwell J, Jakova E, Cayabyab FS. · · 2017 · cited 142× · PMID 28441750 · DOI 10.3390/molecules22040676
Sex-stratified genome-wide association and transcriptome-wide Mendelian randomization studies reveal drug targets of heart failure.
Yang Q, Yang Q, Wu X, Zheng R, et al · · 2024 · cited 10× · PMID 38237596 · DOI 10.1016/j.xcrm.2023.101382
The developmental journey of therapies targeting purine receptors: from basic science to clinical trials.
Han S, Suzuki-Kerr H, Vlajkovic SM, Thorne PR. · · 2022 · cited 9× · PMID 36173587 · DOI 10.1007/s11302-022-09896-w

Verify or expand the search:

Other recruiting trials for Renal Insufficiency

Currently open trials in the same condition.

NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
NCT07001436 — A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insuffici · Phase 1 · recruiting
NCT06431789 — Prospective Observational Association Between SLCO1B1 Gene Polymorphism and the Anti-factor Xa Activity of Edoxaban in P · recruiting
NCT06354231 — DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC · Phase 2 · recruiting
NCT05428631 — Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Ca · NA · recruiting

Other Biogen trials

Trials by the same sponsor.

NCT07483632 — A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses · Phase 3 · not yet recruiting
NCT06628687 — A Study to Learn How BIIB141 (Omaveloxolone) Affects the Health of Participants With Friedrich's Ataxia Who Took it Duri · recruiting
NCT07444450 — A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy · Phase 3 · not yet recruiting
NCT07444489 — A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants · Phase 3 · not yet recruiting
NCT07444476 — A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years Wit · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00709865 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biogen
Last refreshed: 11 September 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00709865.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing