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Trial record 58 of 333 for:    DABIGATRAN

Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

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ClinicalTrials.gov Identifier: NCT01241539
Recruitment Status : Completed
First Posted : November 16, 2010
Results First Posted : July 27, 2012
Last Update Posted : April 7, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Cardiovascular Diseases
Kidney Failure, Chronic
Intervention Drug: Dabigatran etexilate
Enrollment 7
Recruitment Details  
Pre-assignment Details This was an open-label, 2-period, fixed-sequence, multiple dose trial. On Day 1, all patients were treated with Dabigatran 150 mg, on day 2, with 110 mg at 10:00, and on day 3, 75 mg 8 h before dialysis. The target blood flow rate on day 3 of period 1 was 200mL/min, whilst that in period 2 was 400mL/min.
Arm/Group Title Dabigatran
Hide Arm/Group Description Period 1 target blood flow rate during dialysis was 200mL/min. Period 2 target blood flow rate during dialysis was 400mL/min.
Period Title: Period 1
Started 7
Completed 7
Not Completed 0
Period Title: Period 2
Started 7 [1]
Completed 7
Not Completed 0
[1]
After a wash-out phase of at least 6 weeks.
Arm/Group Title Dabigatran
Hide Arm/Group Description Dabigatran treated patients
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
Treated set (TS) included all 7 subjects who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
38.3  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
0
   0.0%
Male
7
 100.0%
1.Primary Outcome
Title Dialysis Clearance of Dabigatran
Hide Description Dialysis clearance of dabigatran from blood (CLD,b) and dialysis clearance of dabigatran from plasma (CLD) were calculated and indicate how quickly dabigatran is cleared out from blood or plasma.
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS) includes all evaluable patients of the treated set who received at least one dose of dabigatran etexilate and who provide at least one observation for at least one Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.
Arm/Group Title Dabigatran P1 Dabigatran P2
Hide Arm/Group Description:
Period 1 target blood flow rate during dialysis was 200mL/min
Period 2 target blood flow rate during dialysis was 400mL/min
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
Total dabigatran clearance (CLD,b) from blood
161
(5.01%)
241
(3.08%)
Total dabigatran clearance (CLD) from plasma
120
(5.09%)
183
(4.30%)
Free dabigatran clearance (CLD,b) from blood
167
(4.60%)
251
(2.17%)
Free dabigatran clearance (CLD) from plasma
124
(4.48%)
190
(3.68%)
2.Primary Outcome
Title Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis
Hide Description Extent of dabigatran that is removed from blood during one complete 4-hour cycle of dialysis was computed by the difference of plasma concentration at the start and at the end of dialysis relative to the start concentration and is therefore measured as a percentage.
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran P1 Dabigatran P2
Hide Arm/Group Description:
Period 1 target blood flow rate during dialysis was 200mL/min
Period 2 target blood flow rate during dialysis was 400mL/min
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage
Total Dabigatran
48.8
(10.9%)
59.3
(6.69%)
Free Dabigatran
49.7
(9.10%)
59.3
(6.13%)
3.Primary Outcome
Title Plasma Concentration Extraction Ratio
Hide Description Plasma concentration extraction ratio was measured directly at the dialysis machine and computed as the difference of the predialysis plasma concentration and the postdialysis plasma concentration relative to the predialysis concentration on the percentage scale (minimum: 0 percent of extraction (worst), maximum: 100 percent of extraction).
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran P1 Dabigatran P2
Hide Arm/Group Description:
Period 1 target blood flow rate during dialysis was 200mL/min
Period 2 target blood flow rate during dialysis was 400mL/min
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Percentage
Total Dabigatran
79.9
(9.01%)
61.4
(9.54%)
Free Dabigatran
82.6
(8.21%)
63.7
(8.60%)
4.Secondary Outcome
Title Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)
Hide Description Area under the concentration-time curve of total and free dabigatran in plasma over the time interval from 0 to 8 hours after the second and third administration of dabigatran.
Time Frame Days 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic set (PKS) includes all evaluable patients of the TS who received at least 1 dose of dabigatran etexilate, who provided at least 1 observation for at least 1 Pharmacokinetics (PK) endpoint, and who did not have important protocol violations relevant to the evaluation of PK
Arm/Group Title Dabigatran P1 Dabigatran P2
Hide Arm/Group Description:
Period 1 target blood flow rate during dialysis was 200mL/min
Period 2 target blood flow rate during dialysis was 400mL/min
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
Total Dabigatran on Day 2
1230
(57.1%)
1140
(39.4%)
Total Dabigatran on Day 3
1280
(54.4%)
1180
(50.2%)
Free Dabigatran on Day 2
907
(51.6%)
802
(44.1%)
Free Dabigatran on Day 3
839
(41.3%)
752
(58.0%)
5.Secondary Outcome
Title Maximum Plasma Concentrations of Dabigatran (Cmax)
Hide Description Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.
Time Frame Days 2 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran P1 Dabigatran P2
Hide Arm/Group Description:
Period 1 target blood flow rate during dialysis was 200mL/min
Period 2 target blood flow rate during dialysis was 400mL/min
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Total Dabigatran on Day 2
194
(53.1%)
171
(36.2%)
Total Dabigatran on Day 3
176
(54.1%)
159
(50.2%)
Free Dabigatran on Day 2
150
(47.3%)
126
(38.1%)
Free Dabigatran on Day 3
119
(43.7%)
105
(57.3%)
6.Secondary Outcome
Title Time to Maximum Plasma Concentration (Tmax)
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
PKS
Arm/Group Title Dabigatran P1 Dabigatran P2
Hide Arm/Group Description:
Period 1 target blood flow rate during dialysis was 200mL/min
Period 2 target blood flow rate during dialysis was 400mL/min
Overall Number of Participants Analyzed 7 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h
Total Dabigatran
1.49
(38.4%)
2.13
(74.1%)
Free Dabigatran
1.35
(38.4%)
1.83
(27.3%)
7.Secondary Outcome
Title Coagulation Parameters
Hide Description Assessment of blood coagulation parameters 'activated partial thromboplastin time' (aPTT) and 'factor IIa inhibition' (anti-FIIa) measured with the diluted thrombin time assay. Time to the formation of a fibrin clot (coagulation) is measured in seconds.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran P1 Dabigatran P2
Hide Arm/Group Description:
Period 1 target blood flow rate during dialysis was 200mL/min
Period 2 target blood flow rate during dialysis was 400mL/min
Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: sec
Activated partial thromboplastin time (aPTT) 46.91  (12.22) 44.26  (10.98)
Factor IIa inhibition (anti-FIIa) 43.27  (7.99) 43.09  (5.38)
8.Secondary Outcome
Title Safety and Tolerability
Hide Description Tolerability refers to the number of non-tolerable patients as assessed through the subjective examination of adverse events (AE). Safety refers to the number of patients with treatment emergent AEs. These numbers are presented on the overall Dabigatran treatment.
Time Frame 2 periods of 5 days each
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran
Hide Arm/Group Description:
Dabigatran treated patients
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Treatment emergent adverse events 2
Assessment of tolerability by the investigator 0
9.Secondary Outcome
Title Additional Safety Parameters
Hide Description By study design abnormalities could be due to dialysis or Dabigatran.
Time Frame 2 periods of 5 days each
Hide Outcome Measure Data
Hide Analysis Population Description
TS
Arm/Group Title Dabigatran
Hide Arm/Group Description:
Dabigatran treated patients
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: Participants
Electrocardiogram (ECG) abnormalities 0
Vital sign abnormalities 0
Physical finding abnormalities 0
Laboratory abnormalities: Haematology 0
Laboratory abnormalities: Clinical chemistry 0
Time Frame 2 periods of 5 days each
Adverse Event Reporting Description Before and after dialysis
 
Arm/Group Title Dabigatran
Hide Arm/Group Description Dabigatran treated patients
All-Cause Mortality
Dabigatran
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran
Affected / at Risk (%)
Total   2/7 (28.57%) 
Nervous system disorders   
Headache  1  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01241539     History of Changes
Other Study ID Numbers: 1160.121
2010-021819-16 ( EudraCT Number: EudraCT )
First Submitted: November 15, 2010
First Posted: November 16, 2010
Results First Submitted: May 10, 2012
Results First Posted: July 27, 2012
Last Update Posted: April 7, 2014