Cardiovascular DiseasesPhase 1NCT01241539

Pharmacokinetics of Dabigatran Etexilate (Pradaxa®) During Haemodialysis

A Phase 1 study testing Dabigatran etexilate in people with Cardiovascular Diseases and Kidney Failure, Chronic, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients. Read more about this study

Who is it for?: Ages 21 to 60 years
Conditions the study is for: Cardiovascular Diseases, Kidney Failure, Chronic
What is being tested?: Dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteGermany
Study dates: Nov 2010to May 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

End stage renally disease (ESRD), undergoing haemodialysis
ESRD patients in relatively good health
Age 21 - 60 years inclusive
Signed and dated written informed consent prior to admission to the study

Who cannot join

Clinically relevant laboratory or physical examination abnormalities (except for renal function tests or deviation of clinical laboratory values) that are related to renal impairment
Moderate and severe concurrent liver function impairment
Surgery of gastrointestinal tract (except appendectomy or herniotomy) or evidence of significant gastrointestinal motility problems
Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding
Intake of medication, which influences the blood clotting
Subjects not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Show all 9Show fewer

For women with childbearing potential: no reliable contraception
Participation in another trial with an investigational drug (<2 months prior to administration or during trial)
Scheduled to receive a donor kidney transplant during the course of the study

Trial locations and contacts

1 site in 1 country.

Germany1 site

1160.121.1 Boehringer Ingelheim Investigational Site
Berlin

Other trials in Germany

About this study

Official title: Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis

The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.

Conditions: Cardiovascular Diseases, Kidney Failure, Chronic
Being tested: Dabigatran etexilate
Medical subject headings: Cardiovascular Diseases, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dabigatran etexilateDrug
150 mg capsule
Dabigatran etexilateDrug
75 mg capsule
Dabigatran etexilateDrug
110 mg capsule

Study groups in NCT01241539
Study group	Role	What they receive
Dabigatran etexilate 110 mg	Experimental	Capsule, oral Receives: Drug: Dabigatran etexilate
Dabigatran etexilate 75 mg	Experimental	Capsule, oral Receives: Drug: Dabigatran etexilate
Dabigatran etexilate 150 mg	Experimental	Capsule, oral Receives: Drug: Dabigatran etexilate

What is being measured

The primary outcome is the main question the study is designed to answer.

Dialysis Clearance of Dabigatran
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.
Measured: 4 hours
Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis
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.
Measured: 4 hours
Plasma Concentration Extraction Ratio
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).
Measured: 4 hours

Secondary outcomes (6)

Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)
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.
Measured: Days 2 and 3
Maximum Plasma Concentrations of Dabigatran (Cmax)
Maximum measured concentration of total and free dabigatran in plasma after the second and third administration of dabigatran.
Measured: Days 2 and 3
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration of total and free dabigatran in plasma after the third administration of dabigatran.
Measured: Day 3
Coagulation Parameters
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.
Measured: Day 3
Safety and Tolerability
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.
Measured: 2 periods of 5 days each
Additional Safety Parameters
By study design abnormalities could be due to dialysis or Dabigatran.
Measured: 2 periods of 5 days each

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010May 2011

First posted16 Nov 2010 (estimated)
Study startNov 2010
Primary completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01241539
Sponsor's protocol ID: 1160.121
Other IDs: 2010-021819-16
Status last verified: Feb 2014
First submitted: 15 Nov 2010
Last updated: 7 Apr 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label, Non Randomized, Multiple Dose Phase I Study to Investigate the Elimination, Pharmacokinetics, Pharmacodynamics and Safety of Dabigatran Etexilate (Pradaxa) Under Steady State Conditions Before, During and After Haemodialysis in Patients With End Stage Renal Disease (ESRD) Undergoing Regular Haemodialysis
ClinicalTrials.gov ID: NCT01241539
Acronym / sponsor ID: 1160.121
Conditions: Cardiovascular Diseases, Kidney Failure, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: May 2011 (actual)
First posted: 16 Nov 2010 (estimated)
Results: Posted 27 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Dabigatran etexilate 110 mg	Experimental	Drug: Dabigatran etexilateCapsule, oral
Dabigatran etexilate 75 mg	Experimental	Drug: Dabigatran etexilateCapsule, oral
Dabigatran etexilate 150 mg	Experimental	Drug: Dabigatran etexilateCapsule, oral

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

End stage renally disease (ESRD), undergoing haemodialysis
ESRD patients in relatively good health
Age 21 - 60 years inclusive
Signed and dated written informed consent prior to admission to the study

Key exclusion criteria (9 listed)

Clinically relevant laboratory or physical examination abnormalities (except for renal function tests or deviation of clinical laboratory values) that are related to renal impairment
Moderate and severe concurrent liver function impairment
Surgery of gastrointestinal tract (except appendectomy or herniotomy) or evidence of significant gastrointestinal motility problems
Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding
Intake of medication, which influences the blood clotting

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dabigatran etexilate150 mg capsule	Drug	Dabigatran etexilate 150 mg
Dabigatran etexilate75 mg capsule	Drug	Dabigatran etexilate 75 mg
Dabigatran etexilate110 mg capsule	Drug	Dabigatran etexilate 110 mg

Primary outcome

Dialysis Clearance of Dabigatran
Time frame: 4 hours
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.
Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis
Time frame: 4 hours
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.
Plasma Concentration Extraction Ratio
Time frame: 4 hours
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).

6 secondary outcomes

Area Under the Curve Exposure to Dabigatran During the First 8 Hours Post Dose (AUC0-8h)
Time frame: Days 2 and 3
Maximum Plasma Concentrations of Dabigatran (Cmax)
Time frame: Days 2 and 3
Time to Maximum Plasma Concentration (Tmax)
Time frame: Day 3
Coagulation Parameters
Time frame: Day 3
Safety and Tolerability
Time frame: 2 periods of 5 days each
Additional Safety Parameters
Time frame: 2 periods of 5 days each

Results and safety

Results posted to the registry on 27 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran	7	7

Primary outcome: Dialysis Clearance of Dabigatran

Time frame: 4 hours. Geometric mean (Geometric Coefficient of Variation). Unit: mL/min

Measure	Dabigatran P1 n = 7	Dabigatran P2 n = 7
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)

Population analysed: 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.

Primary outcome: Extent Cleared From Circulation (Plasma) During 1 Complete Cycle of Dialysis

Time frame: 4 hours. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage

Measure	Dabigatran P1 n = 7	Dabigatran P2 n = 7
Total Dabigatran	48.8 (10.9)	59.3 (6.69)
Free Dabigatran	49.7 (9.10)	59.3 (6.13)

Population analysed: PKS

Primary outcome: Plasma Concentration Extraction Ratio

Time frame: 4 hours. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage

Measure	Dabigatran P1 n = 7	Dabigatran P2 n = 7
Total Dabigatran	79.9 (9.01)	61.4 (9.54)
Free Dabigatran	82.6 (8.21)	63.7 (8.60)

Population analysed: PKS

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 periods of 5 days each. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran	0 of 7 (0%)	2 of 7 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dabigatran etexilate in people with Cardiovascular Diseases and Kidney Failure, Chronic, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dialysis Clearance of Dabigatran (time frame: 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01241539.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2014.