Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.

Boehringer Ingelheim19 enrolled

Overview

The study to be conducted is a prospective, open label trial. It is designed to evaluate the pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate in patients with chronic kidney disease.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Insufficiency, Chronic

Interventions

Dabigatran EtexilateDRUG

Dabigatran Etexilate 75mg twice daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Male and female patients aged 18 years and older 2. Impaired renal function defined as a stable Cockcroft-Gault and/or actual creatinine clearance between 15-30 ml/min over the last 3 months before study participation. 3. The single use of either aspirin or Vitamin K Antagonists 4. Provision of informed consent. Exclusion criteria: 1. Unstable renal function and Creatinin Clearance \<15mL/min 2. Patients treated with two or more platelet aggregation inhibitors 3. Use of or indication for therapeutic heparin 4. Patients with prosthetic heart valves 5. Haemorrhagic disorder or bleeding diathesis 6. Platelet count \<100 109/L) at screening or during the last 30 days before screening. 7. Participation in another drug trial in the last 30 days before screening.

Locations (1)

1160.166.31001 Boehringer Ingelheim Investigational Site

Leiden, Netherlands

Outcomes

Primary Outcomes

Cmax,ss

Maximum concentration of Dabigatran etexilate in plasma at steady state was measured. The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration.

Time frame: -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h

AUCtau,ss

Area under the plasma concentration-time curve of the total dabigatran at steady state over a uniform dosing interval tau was measured. The samples for pharmacokinetics had to be taken from 30 min before drug administration up to 11 days after drug administration.

Time frame: -0.5 hours (h), 0.5h, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 23.5h, 47.5h, 71.5h, 95.5h, 119.5h, 155.5h, 167.5h, 168.5h, 169h, 170h, 171h, 172h, 174h, 176h, 179.5h, 180h, 192h, 216h, 240h

Data from ClinicalTrials.gov

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