Clinical trial NCT01896297: Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
Official title: A Prospective, Open Label Study to Evaluate the Pharmacokinetics of Dabigatran in Non-valvular Atrial Fibrillation (NVAF) Patients With Severely Impaired Renal Function on Dabigatran Etexilate 75 mg BID Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.

The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.


Eligibility criteria: Inclusion criteria:

* Subjects diagnosed with non-valvular atrial fibrillation with an indication for the anticoagulation therapy,
* Subjects with severe renal function impairment defined as creatinine clearance between 15 and 30 mL/min by Cockcroft-Gault formula,
* Male and female patients, age =18 years at entry

Exclusion criteria:

* Contraindications to Pradaxa (history of a serious hypersensitivity reaction to Pradaxa, active pathological bleeding, patients with mechanical prosthetic heart valve),
* Creatinine clearance \<15ml/min or patients with End Stage Renal Disease on dialysis,
* Creatinine clearance \>30 ml/min,
* Pre-menopausal women (last menstruation less than one year prior to informed consent) who are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, double barrier method and vasectomised partner,
* Patients who are participating in another drug study,
* Patients who have participated in another drug study within 6 weeks,
* Patients considered unreliable by the investigator concerning the requirements for participating in the study, including a follow-up interview,
* Any condition the investigator believes would not allow safe participation in the study,

Primary outcomes:
measure: Pre-dose Concentration of the Analyte in Plasma at Steady State Immediately Before Administration of the Next Dose
timeFrame: Immediately before the last drug administration, on day 8
measure: Concentration of Analyte in Plasma at Steady State at 2 Hours After Administration of the Last Dose
timeFrame: 2 hours after the last drug administration, on day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: 1160.173.002 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Fremont
country: United States
facility: 1160.173.023 Boehringer Ingelheim Investigational Site
state: California
city: Moreno Valley
country: United States
facility: 1160.173.032 Boehringer Ingelheim Investigational Site
state: California
city: Oceanside
country: United States
facility: 1160.173.034 Boehringer Ingelheim Investigational Site
state: California
city: Salinas
country: United States
facility: 1160.173.025 Boehringer Ingelheim Investigational Site
state: California
city: San Pedro
country: United States
facility: 1160.173.033 Boehringer Ingelheim Investigational Site
state: California
city: Wilmington
country: United States
facility: 1160.173.024 Boehringer Ingelheim Investigational Site
state: Delaware
city: Washington
country: United States
facility: 1160.173.010 Boehringer Ingelheim Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: 1160.173.020 Boehringer Ingelheim Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: 1160.173.036 Boehringer Ingelheim Investigational Site
state: Florida
city: Largo
country: United States
facility: 1160.173.012 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1160.173.013 Boehringer Ingelheim Investigational Site
state: Florida
city: Columbus
country: United States
facility: 1160.173.005 Boehringer Ingelheim Investigational Site
state: Georgia
city: Springfield
country: United States
facility: 1160.173.018 Boehringer Ingelheim Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: 1160.173.019 Boehringer Ingelheim Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: 1160.173.026 Boehringer Ingelheim Investigational Site
state: Missouri
city: Neptune
country: United States
facility: 1160.173.027 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Wilmington
country: United States
facility: 1160.173.014 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Altoona
country: United States
facility: 1160.173.001 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 1160.173.008 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: 1160.173.037 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: 1160.173.030 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: 1160.173.011 Boehringer Ingelheim Investigational Site
state: Texas
city: Live Oak
country: United States
facility: 1160.173.006 Boehringer Ingelheim Investigational Site
state: Texas
city: Norfolk
country: United States
facility: 1160.173.021 Boehringer Ingelheim Investigational Site
state: Virginia
city: Waukesha
country: United States
facility: 1160.173.035 Boehringer Ingelheim Investigational Site
state: Wisconsin
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Martin JL, Esmaeili H, Manuel RC, Petrini M, Wiebe S, Maas H. Pharmacokinetics/Pharmacodynamics of Dabigatran 75 mg Twice Daily in Patients With Nonvalvular Atrial Fibrillation and Severely Impaired Renal Function. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):399-406. doi: 10.1177/1074248418769167. Epub 2018 Apr 25.