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

Renal Insufficiency, Chronic Clinical Trial

Official title:

An Exploratory Study to Investigate the Pharmacokinetics and Effects of DABIgatran Etexilate in Patients With Stable Severe RENAL Disease: DabiRenal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711853
• Other study ID #: 1160.166
• Secondary ID: 2011-003081-32
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2012
• Last updated: January 9, 2015
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Central Committee Research Involving Human Subjects
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Dabigatran Etexilate
Dabigatran Etexilate 75mg twice daily

Locations

Country	Name	City	State
Netherlands	1160.166.31001 Boehringer Ingelheim Investigational Site	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	-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	No
Primary	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.	-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	No

External Links

•   Related Info