Renal Insufficiency, ChronicPhase 1NCT01711853

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

A Phase 1 study testing Dabigatran Etexilate in people with Renal Insufficiency, Chronic, run by Boehringer Ingelheim at 1 site in Netherlands.

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 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Renal Insufficiency, 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: 19 participants
Where: 1 siteNetherlands
Study dates: Oct 2012to Dec 2013
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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients aged 18 years and older
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.
The single use of either aspirin or Vitamin K Antagonists
Provision of informed consent.

Who cannot join

Unstable renal function and Creatinin Clearance <15mL/min
Patients treated with two or more platelet aggregation inhibitors
Use of or indication for therapeutic heparin
Patients with prosthetic heart valves
Haemorrhagic disorder or bleeding diathesis
Platelet count <100 109/L) at screening or during the last 30 days before screening.
Participation in another drug trial in the last 30 days before screening.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

1160.166.31001 Boehringer Ingelheim Investigational Site
Leiden

Other trials in Netherlands

About this study

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

Conditions: Renal Insufficiency, Chronic
Being tested: Dabigatran Etexilate
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

Dabigatran EtexilateDrug
Dabigatran Etexilate 75mg twice daily

Study groups in NCT01711853
Study group	Role	What they receive
Dabigatran Etexilate	Experimental	patient to receive a capsule containing 75 mg of dabigatran etexilate Receives: Drug: Dabigatran Etexilate

What is being measured

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

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.
Measured: -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
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.
Measured: -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

Timeline

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

Oct 2012Dec 2013

First posted22 Oct 2012 (estimated)
Study startOct 2012
Primary completionDec 2013
Study completionDec 2013

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 Renal Insufficiency, ChronicStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01711853
Sponsor's protocol ID: 1160.166
Other IDs: 2011-003081-32
Status last verified: Jan 2015
First submitted: 19 Oct 2012
Last updated: 13 Jan 2015
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?

See locations

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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Hypothermic Kidney Machine Perfusion With Omnisol
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An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
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All Renal Insufficiency, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study to Investigate the Pharmacokinetics and Effects of DABIgatran Etexilate in Patients With Stable Severe RENAL Disease: DabiRenal
ClinicalTrials.gov ID: NCT01711853
Acronym / sponsor ID: 1160.166
Conditions: Renal Insufficiency, Chronic
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Dec 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 22 Oct 2012 (estimated)
Results: Posted 13 Jan 2015

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dabigatran Etexilate	Experimental	Drug: Dabigatran Etexilatepatient to receive a capsule containing 75 mg of dabigatran etexilate

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male and female patients aged 18 years and older
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.
The single use of either aspirin or Vitamin K Antagonists
Provision of informed consent.

Key exclusion criteria (7 listed)

Unstable renal function and Creatinin Clearance <15mL/min
Patients treated with two or more platelet aggregation inhibitors
Use of or indication for therapeutic heparin
Patients with prosthetic heart valves
Haemorrhagic disorder or bleeding diathesis

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 EtexilateDabigatran Etexilate 75mg twice daily	Drug	Dabigatran Etexilate

Primary outcome

Cmax,ss
Time frame: -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
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.
AUCtau,ss
Time frame: -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
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.

Results and safety

Results posted to the registry on 13 Jan 2015, 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 75 mg	19	16

Primary outcome: Cmax,ss

Time frame: -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. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Dabigatran 75 mg n = 15
Value	207 (53.9)

Dabigatran 75 mg: p = 0.5186, ANOVA
Dabigatran 75 mg: p = 0.9883, ANOVA
Dabigatran 75 mg: p = 0.7853, ANOVA

Population analysed: Pharmacokinetic set (PKS) which included all treated subjects that provided at least 1 observation for at least 1 primary pharmacokinetic endpoint without important protocol violations with respect to the evaluation of the pharmacokinetic endpoints and with predose values not greater than 5% of Cmax.

Primary outcome: AUCtau,ss

Measure	Dabigatran 75 mg n = 15
Value	2140 (51.9)

Dabigatran 75 mg: p = 0.4692, ANOVA
Dabigatran 75 mg: p = 0.9734, ANOVA
Dabigatran 75 mg: p = 0.9201, ANOVA

Population analysed: PKS

Adverse events

Time frame: Up to Day 11. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran 75 mg	0 of 16 (0%)	6 of 16 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Renal Insufficiency, Chronic

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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 Renal Insufficiency, Chronic, run by Boehringer Ingelheim at 1 site in Netherlands.

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 7 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 13 Jan 2015. 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 Netherlands. 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 13 Jan 2015). 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?

Cmax,ss (time frame: -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). The study lists 2 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 NCT01711853.

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 13 Jan 2015.