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

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ClinicalTrials.gov Identifier: NCT01711853
Recruitment Status : Completed
First Posted : October 22, 2012
Results First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Drug: Dabigatran Etexilate Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Investigate the Pharmacokinetics and Effects of DABIgatran Etexilate in Patients With Stable Severe RENAL Disease: DabiRenal
Study Start Date : October 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dabigatran Etexilate
patient to receive a capsule containing 75 mg of dabigatran etexilate
Drug: Dabigatran Etexilate
Dabigatran Etexilate 75mg twice daily


Outcome Measures

Primary Outcome Measures :
  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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male and female patients aged 18 years and older
  2. 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.
  3. The single use of either aspirin or Vitamin K Antagonists
  4. Provision of informed consent.

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711853


Locations
Netherlands
1160.166.31001 Boehringer Ingelheim Investigational Site
Leiden, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01711853     History of Changes
Other Study ID Numbers: 1160.166
2011-003081-32 ( EudraCT Number: EudraCT )
First Posted: October 22, 2012    Key Record Dates
Results First Posted: January 13, 2015
Last Update Posted: January 13, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Dabigatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants