Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Brief Summary

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The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.

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Detailed Description

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Conditions

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Cardiovascular Diseases Kidney Failure, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Dabigatran etexilate 110 mg

Capsule, oral

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

110 mg capsule

Dabigatran etexilate 75 mg

Capsule, oral

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

75 mg capsule

Dabigatran etexilate 150 mg

Capsule, oral

Group Type EXPERIMENTAL

Dabigatran etexilate

Intervention Type DRUG

150 mg capsule

Interventions

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Dabigatran etexilate

150 mg capsule

Intervention Type DRUG

Dabigatran etexilate

75 mg capsule

Intervention Type DRUG

Dabigatran etexilate

110 mg capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* End stage renally disease (ESRD), undergoing haemodialysis
* ESRD patients in relatively good health
* Age 21 - 60 years inclusive
* Signed and dated written informed consent prior to admission to the study

Exclusion Criteria

* Clinically relevant laboratory or physical examination abnormalities (except for renal function tests or deviation of clinical laboratory values) that are related to renal impairment
* Moderate and severe concurrent liver function impairment
* Surgery of gastrointestinal tract (except appendectomy or herniotomy) or evidence of significant gastrointestinal motility problems
* Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding
* Intake of medication, which influences the blood clotting
* Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
* For women with childbearing potential: no reliable contraception
* Participation in another trial with an investigational drug (\<2 months prior to administration or during trial)
* Scheduled to receive a donor kidney transplant during the course of the study

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No