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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01241539
Other study ID # 1160.121
Secondary ID 2010-021819-16
Status Completed
Phase Phase 1
First received November 15, 2010
Last updated February 24, 2014
Start date November 2010

Study information

Verified date February 2014
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 60 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label


Intervention

Drug:
Dabigatran etexilate
150 mg capsule
Dabigatran etexilate
75 mg capsule
Dabigatran etexilate
110 mg capsule

Locations

Country Name City State
Germany 1160.121.1 Boehringer Ingelheim Investigational Site Berlin

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dialysis Clearance of Dabigatran 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. 4 hours No
Primary Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis 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. 4 hours No
Primary Plasma Concentration Extraction Ratio 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). 4 hours No
Secondary Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h) 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. Days 2 and 3 No
Secondary Maximum Plasma Concentrations of Dabigatran (Cmax) Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran. Days 2 and 3 No
Secondary Time to Maximum Plasma Concentration (Tmax) Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran. Day 3 No
Secondary Coagulation Parameters 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. Day 3 No
Secondary Safety and Tolerability 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. 2 periods of 5 days each No
Secondary Additional Safety Parameters By study design abnormalities could be due to dialysis or Dabigatran. 2 periods of 5 days each No
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