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Completed

NCT Number: NCT01711853

Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.

The study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.

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Key information

Conditions

Renal Insufficiency, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

1160.166.31001 Boehringer Ingelheim Investigational Site

Leiden, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female patients aged 18 years and older
  • Impaired renal function defined as a stable Cockcroft-Gault and/or actual creatinine clearance between 15-30 ml/min over the last 3 months before study participation.
  • The single use of either aspirin or Vitamin K Antagonists
  • Provision of informed consent.

Exclusion criteria

  • Unstable renal function and Creatinin Clearance <15mL/min
  • Patients treated with two or more platelet aggregation inhibitors
  • Use of or indication for therapeutic heparin
  • Patients with prosthetic heart valves
  • Haemorrhagic disorder or bleeding diathesis
  • Platelet count <100 109/L) at screening or during the last 30 days before screening.
  • Participation in another drug trial in the last 30 days before screening.

Treatment and study plan

Dabigatran Etexilate

Drug

Dabigatran Etexilate 75mg twice daily

Primary outcomes

  1. Cmax,ss

    Time frame: -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h

    Maximum concentration of Dabigatran etexilate in plasma at steady state was measured.

    The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration.

  2. AUCtau,ss

    Time frame: -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h

    Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured.

    The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

An Exploratory Study to Investigate the Pharmacokinetics and Effects of DABIgatran Etexilate in Patients With Stable Severe RENAL Disease: DabiRenal

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2012
Registry last updated
Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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