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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Insufficiency, Chronic

Intervention / Treatment
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* Drug: Dabigatran Etexilate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dabigatran Etexilate<br>patient to receive a capsule containing 75 mg of dabigatran etexilate | Drug: Dabigatran Etexilate<br>* Dabigatran Etexilate 75mg twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | -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 | 
| 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. | -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 |