At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 19 enrolled
Drug / intervention
Dabigatran Etexilatedrug
Likely dose
Dabigatran Etexilate 75mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Exploratory Study to Investigate the Pharmacokinetics and Effects of DABIgatran Etexilate in Patients With Stable Severe RENAL Disease: DabiRenal
In Brief
A Phase 1 clinical trial evaluating Dabigatran Etexilate for Renal Insufficiency, Chronic. Completed, enrolled 19 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Insufficiency, Chronic
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2012
First PostedOct 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedOct 22, 2012
Enrollment StartOct 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.7 years ago
Interventions
Dabigatran Etexilatedrug
Dabigatran Etexilate 75mg twice daily