Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function

Study Overview
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Brief Summary
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The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula. The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.

Official Title
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A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Pradaxa, dabigatran etexilate


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy, Subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 mL/min by Cockcroft-Gault formula, Male and female patients, age =18 years at entry Exclusion criteria: Contraindications to Pradaxa (history of a serious hypersensitivity reaction to Pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve), Creatinine clearance <15ml/min or patients with End Stage Renal Disease on dialysis, Creatinine clearance >30 ml/min, Pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner, Patients who are participating in another drug study, Patients who have participated in another drug study within 6 weeks, Patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview, Any condition the investigator believes would not allow safe participation in the study,

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Other: dabigatran etexilate<br>75mg BID by oral | Drug: Pradaxa, dabigatran etexilate<br>* 75mg BID by oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose | Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose (Cpre,ss) taken at approximately 12 hours after the last dose (trough). | Immediately before the last drug administration, on day 8 | 
| Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose | Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose (C2,ss) | 2 hours after the last drug administration, on day 8 |