Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

Phase 1

Completed

• Conditions: Cardiovascular Diseases; Kidney Failure, Chronic
• Interventions: Drug: Dabigatran etexilate

• Registration Number: NCT01241539
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Primary Completion: 2011-05
• Results First Submitted: 2012-05-10
• Results First Submitted QC: 2012-06-21
• Results First Posted: 2012-07-27
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-24
• Last Update Posted: 2014-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dabigatran etexilate 110 mg	Dabigatran etexilate	Capsule, oral
Dabigatran etexilate 75 mg	Dabigatran etexilate	Capsule, oral
Dabigatran etexilate 150 mg	Dabigatran etexilate	Capsule, oral

Primary Outcome Measures

Name	Time	Method
Dialysis Clearance of Dabigatran	4 hours	Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.
Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis	4 hours	Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.
Plasma Concentration Extraction Ratio	4 hours	Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)	Days 2 and 3	Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran.
Time to Maximum Plasma Concentration (Tmax)	Day 3	Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran.
Maximum Plasma Concentrations of Dabigatran (Cmax)	Days 2 and 3	Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.
Coagulation Parameters	Day 3	Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds.
Safety and Tolerability	2 periods of 5 days each	Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment.
Additional Safety Parameters	2 periods of 5 days each	By study design abnormalities could be due to dialysis or Dabigatran.

Trial Locations

Locations (1)

1160.121.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany