Dabigatran, an anticoagulant drug in patients with impaired renal functio

• Conditions: Chronic kidney disease and coagulation; MedDRA version: 14.1Level: PTClassification code 10038444Term: Renal failure chronicSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-003081-32-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-24
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age: 18 years and older
• Able and willing to give informed consent
• Impaired renal function defined as a stable MDRD and/or creatinine clearance
estimated using urinary excretion between 15-30 ml/min over the last 3 months
before study participation
• The single use of either aspirin or Vitamin K-antagonists
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Instable renal function (i.e. an increase in serum creatinine > 20% in the last three months)
-Patients treated with two or more platelet aggregation inhibitors
-Use of or indication for therapeutic (low molecular weight) heparin
-Patients with mechanic heart valves
-Any known bleeding disorder or tendency
- Uncontrolled hypertension (systolic >180mmHg or diastolic >100mmHg)
- Diabetes mellitus with active retinopathy
- Pre-menopausal women not willing to use appropriate contraception (e.g. oral anti conceptive
drugs or intrauterine devices)
- Recent cerebral bleeding or cranio-cerebral trauma (within the last six months)
- Moderate to severe liver impairment (ALT >2 ULN)
- Gastrointestinal surgery within the last three months (except for appendectomy,
cholecystectomy or herniotomy)
- Use of P-glycoprotein inhibitors
- Relevant acute infections (e.g. acute pneumonia)
- History of allergy or hypersensitivity (including drug allergies) deemed relevant by the
investigator
- Planned diagnostic or therapeutic procedures with potential for uncontrollable bleeding within
30 days before, during or after the trial
- Indication of past of present use of drugs or abuse
- Past history of alcoholism with clinical sequelae or present use of alcohol >3U daily (male)
or 2U daily (female)
- Participation in another drug trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified