Back to resultsStudy to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
Primary Purpose
Renal Insufficiency, Chronic
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Dabigatran Etexilate
Sponsored by
About this trial
This is an interventional treatment trial for Renal Insufficiency, Chronic
Eligibility Criteria
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.
Sites / Locations
- 1160.166.31001 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dabigatran Etexilate
Arm Description
patient to receive a capsule containing 75 mg of dabigatran etexilate
Outcomes
Primary Outcome Measures
Cmax,ss
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.
AUCtau,ss
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01711853
Brief Title
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
Official Title
An Exploratory Study to Investigate the Pharmacokinetics and Effects of DABIgatran Etexilate in Patients With Stable Severe RENAL Disease: DabiRenal
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dabigatran Etexilate
Arm Type
Experimental
Arm Description
patient to receive a capsule containing 75 mg of dabigatran etexilate
Intervention Type
Drug
Intervention Name(s)
Dabigatran Etexilate
Intervention Description
Dabigatran Etexilate 75mg twice daily
Primary Outcome Measure Information:
Title
Cmax,ss
Description
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.
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
Title
AUCtau,ss
Description
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.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1160.166.31001 Boehringer Ingelheim Investigational Site
City
Leiden
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
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