Clinical trial NCT01241539: Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis
Official title: Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cardiovascular Diseases
Kidney Failure, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-11-16
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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


Eligibility criteria: 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

Primary outcomes:
measure: Dialysis Clearance of Dabigatran
timeFrame: 4 hours
measure: Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis
timeFrame: 4 hours
measure: Plasma Concentration Extraction Ratio
timeFrame: 4 hours
Secondary outcomes:
measure: Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)
timeFrame: Days 2 and 3
measure: Maximum Plasma Concentrations of Dabigatran (Cmax)
timeFrame: Days 2 and 3
measure: Time to Maximum Plasma Concentration (Tmax)
timeFrame: Day 3
measure: Coagulation Parameters
timeFrame: Day 3
measure: Safety and Tolerability
timeFrame: 2 periods of 5 days each
measure: Additional Safety Parameters
timeFrame: 2 periods of 5 days each
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: 1160.121.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: