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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency, Chronic

Treatments: Drug: Dabigatran Etexilate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01711853

1160.166

2011-003081-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Dabigatran Etexilate

Experimental group

Description:

patient to receive a capsule containing 75 mg of dabigatran etexilate

Treatment:

Drug: Dabigatran Etexilate