End Stage Renal DiseasePhase 1NCT01340586

Pharmacokinetics and Pharmacodynamics of Apixaban in Subjects on Hemodialysis

A Phase 1 study testing Apixaban in people with End Stage Renal Disease, run by Bristol-Myers Squibb at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to assess the pharmacokinetics of a single oral dose of 5 mg Apixaban in subjects with normal renal function and subjects with end stage renal disease (ESRD) maintained with hemodialysis. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: End Stage Renal Disease
What is being tested?: Apixaban
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Sep 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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The signed informed consent form.
Subjects with normal renal function classified based on calculated creatinine clearance (CLCr) determined by the cockcroft-gault calculation.
Eligible subjects with ESRD that is maintained with chronic and stable hemodialysis.

Who cannot join

Any history of abnormal bleeding or coagulation disorders including those in a first degree relative under 50 years of age.
History of significant head injury within the last two years.
Any gastrointestinal surgery that could impact the absorption of study drug.
Not expected to continue the hemodialysis treatment for the duration of the study.
INR, PT, or aPTT above the upper limit of normal, unless agreed upon between the investigator and BMS medical monitor.
History of allergy to Apixaban or Factor Xa inhibitors.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Orlando, Florida

Other trials in United States

About this study

Official title: Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban in Subjects on Hemodialysis

Read the detailed description

Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .

Conditions: End Stage Renal Disease
Being tested: Apixaban
Keywords: PHARMACOKINETIC, NOS
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

ApixabanDrug
Tablets, Oral, 5 mg, Once, 4 days
ApixabanDrug
Tablets, Oral, 5 mg, Twice, 15 days

Study groups in NCT01340586
Study group	Role	What they receive
Group A: Apixaban	Experimental	Not described Receives: Drug: Apixaban
Group B: Apixaban	Experimental	Not described Receives: Drug: Apixaban

What is being measured

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

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL).
Measured: 24 hours pre-dose to 72 hours post-dose
Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanograms per milliliter (ng/mL).
Measured: From 24 hours pre-dose to 72 hours post-dose
Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Measured: 24 hours pre-dose to 72 hours post-dose
Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Measured: From 24 hours pre-dose to 72 hours post-dose
Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban
The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Measured: From 24 hours pre-dose to 72 hours post-dose
Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823
The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Measured: 24 hours pre-dose to 72 hours post-dose
Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban
Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours.
Measured: From 24 hours pre-dose to 72 hours post-dose
Mean Plasma Terminal Half-life (T-Half) of BMS-730823
Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data.
Measured: 24 hours pre-dose to 72 hours post-dose
Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban
Time of maximum observed plasma concentration (Tmax) for apixaban was derived from plasma concentrations versus time data. Medians were reported in hours.
Measured: From 24 hours pre-dose to 72 hours post-dose
Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823
Time of maximum observed plasma concentration (Tmax) for BMS-730823 was derived from plasma concentrations versus time data. Medians were reported in hours.
Measured: From 24 hours pre-dose to 72 hours post-dose
Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban
Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.
Measured: 2 to 6 hours post-dose
Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823
Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.
Measured: 2 to 6 hours post-dose
Mean Percent Dose of Apixaban Recovered in Urine (%UR)
The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered.
Measured: 24 hours pre-dose to 72 hours post-dose
Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)
Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1.
Measured: 2 to 6 hours post-dose
Mean Renal Clearance (CLR) of Apixaban
Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).
Measured: 24 hours pre-dose to 72 hours post-dose
Mean Renal Clearance (CLR) of BMS-730823
Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).
Measured: 24 hours pre-dose to 72 hours post-dose
Mean Hemodialysis Clearance (CLD) of Apixaban
Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).
Measured: 2 to 6 hours post-dose
Mean Hemodialysis Clearance (CLD) of BMS-730823
Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).
Measured: 2 to 6 hours post-dose
Percentage of Apixaban Extracted During Hemodialysis
The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6) exiting - AUC(2-6) entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.
Measured: 2 to 6 hours post-dose
Percentage of BMS-730823 Extracted During Hemodialysis
The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6)exiting - AUC(2-6)entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.
Measured: 2 to 6 hours post-dose

Secondary outcomes (4)

Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban
The mean maximum percent change in baseline for INR was reported for each arm. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.
Measured: From 24 hours pre-dose to 72 hours post-dose
Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban
The mean maximum percent change in Prothrombin Time (PT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.
Measured: From 24 hours pre-dose to 72 hours post-dose
Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban
The mean maximum percent change in Activated Partial Thromboplastin Time (aPTT) from baseline was reported for all treated participants. Baseline measurements were assessed up to 24 hours prior to Day 1 dosing.
Measured: From 24 hours pre-dose to 72 hours post-dose
Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban
Anti-FXa activity was assessed from an activity-time profile for doses both before and after hemodialysis. Maximal means were reported in International Units per milliliter (IU/mL).
Measured: From 24 hours pre-dose to 72 hours post-dose

Timeline

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

Jun 2011Sep 2011

First posted22 Apr 2011 (estimated)
Study startJun 2011
Primary completionSep 2011
Study completionSep 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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: Parallel groups
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340586
Sponsor's protocol ID: CV185-087
Status last verified: Aug 2016
First submitted: 21 Apr 2011
Last updated: 11 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wang X, Tirucherai G, Marbury TC, Wang J, Chang M, Zhang D, Song Y, Pursley J, Boyd RA, Frost C. Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis. J Clin Pharmacol. 2016 May;56(5):628-36. doi: 10.1002/jcph.628. Epub 2015 Dec 22.
PubMed 26331581

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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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Apixaban in Subjects on Hemodialysis
ClinicalTrials.gov ID: NCT01340586
Acronym / sponsor ID: CV185-087
Conditions: End Stage Renal Disease
Keywords: PHARMACOKINETIC, NOS
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 22 Apr 2011 (estimated)
Results: Posted 11 Oct 2016

Clinical summary

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

Detailed description

Primary Purpose : To provide a clear understanding of the pharmacokinetics of Apixaban in subjects with ESRD and to determine the effect of hemodialysis on Apixaban pharmacokinetics .

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A: Apixaban	Experimental	Drug: Apixaban
Group B: Apixaban	Experimental	Drug: Apixaban

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

The signed informed consent form.
Subjects with normal renal function classified based on calculated creatinine clearance (CLCr) determined by the cockcroft-gault calculation.
Eligible subjects with ESRD that is maintained with chronic and stable hemodialysis.

Key exclusion criteria (6 listed)

Any history of abnormal bleeding or coagulation disorders including those in a first degree relative under 50 years of age.
History of significant head injury within the last two years.
Any gastrointestinal surgery that could impact the absorption of study drug.
Not expected to continue the hemodialysis treatment for the duration of the study.
INR, PT, or aPTT above the upper limit of normal, unless agreed upon between the investigator and BMS medical monitor.

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
ApixabanTablets, Oral, 5 mg, Once, 4 days	Drug	Group A: Apixaban
ApixabanTablets, Oral, 5 mg, Twice, 15 days	Drug	Group B: Apixaban

Primary outcome

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban
Time frame: 24 hours pre-dose to 72 hours post-dose
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanograms per milliliter (ng/mL).
Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823
Time frame: From 24 hours pre-dose to 72 hours post-dose
Maximum observed plasma concentration (Cmax) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanograms per milliliter (ng/mL).
Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban
Time frame: 24 hours pre-dose to 72 hours post-dose
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823
Time frame: From 24 hours pre-dose to 72 hours post-dose
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Single 5mg Oral Dose of Apixaban
Time frame: From 24 hours pre-dose to 72 hours post-dose
The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of apixaban over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Geometric Mean of Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-730823
Time frame: 24 hours pre-dose to 72 hours post-dose
The area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) was measured by plasma concentration of BMS-730823 over time. The geometric means are reported in nanogram hours per milliliter (ng*h/mL).
Mean Plasma Terminal Half-life (T-Half) of Single 5mg Oral Dose of Apixaban
Time frame: From 24 hours pre-dose to 72 hours post-dose
Plasma terminal half-life (T-Half) for apixaban was derived from plasma concentrations versus time data. Means were reported in hours.
Mean Plasma Terminal Half-life (T-Half) of BMS-730823
Time frame: 24 hours pre-dose to 72 hours post-dose
Mean plasma terminal half-life (T-Half) for BMS-730823 was derived from plasma concentrations versus time data.
Median Time of Maximum Observed Plasma Concentration (Tmax) of a Single 5 mg Oral Dose of Apixaban
Time frame: From 24 hours pre-dose to 72 hours post-dose
Time of maximum observed plasma concentration (Tmax) for apixaban was derived from plasma concentrations versus time data. Medians were reported in hours.
Median Time of Maximum Observed Plasma Concentration (Tmax) of Metabolite BMS-730823
Time frame: From 24 hours pre-dose to 72 hours post-dose
Time of maximum observed plasma concentration (Tmax) for BMS-730823 was derived from plasma concentrations versus time data. Medians were reported in hours.
Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for Apixaban
Time frame: 2 to 6 hours post-dose
Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for Apixaban was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.
Geometric Mean of Area Under the Plasma Concentration-Time Curve From 2 to 6 Hours (AUC(2-6)) for BMS-730823
Time frame: 2 to 6 hours post-dose
Area under the plasma concentration-time curve from 2 hours to 6 hours (AUC(2-6) for BMS-730823 was measured in participants with ESRD during dialysis in Period 1 only. Geometric Means were reported in nanogram hours per milliliter (ng*hr/mL) and were determined from blood samples both entering and exiting the dialyzer.
Mean Percent Dose of Apixaban Recovered in Urine (%UR)
Time frame: 24 hours pre-dose to 72 hours post-dose
The percent dose recovered in urine was calculated by dividing the cumulative amount of unchanged apixaban excreted in urine from the time of dose up to 72 hours post-dose by the apixaban dose administered.
Mean Percent Dose of Apixaban Recovered in Dialysate (%DR)
Time frame: 2 to 6 hours post-dose
Percent dose of Apixaban recovered in dialysate (%DR) was calculated by dividing the cumulative amount of apixaban excreted in each dialysate collection over 2-6 hours (DR(2-6)) by the apixaban dose. %DR was recorded only in period 1.
Mean Renal Clearance (CLR) of Apixaban
Time frame: 24 hours pre-dose to 72 hours post-dose
Renal clearance (CLR) was calculated by dividing the cumulative amount of apixaban excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).
Mean Renal Clearance (CLR) of BMS-730823
Time frame: 24 hours pre-dose to 72 hours post-dose
Renal clearance (CLR) was calculated by dividing the cumulative amount of BMS-730823 excreted in urine by the respective cumulative plasma AUC over the same urine collection interval. Geometric means were reported in milliliters per minute (mL/min).
Mean Hemodialysis Clearance (CLD) of Apixaban
Time frame: 2 to 6 hours post-dose
Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of apixaban excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).
Mean Hemodialysis Clearance (CLD) of BMS-730823
Time frame: 2 to 6 hours post-dose
Hemodialysis clearance (CLD) was calculated by dividing the cumulative amount of BMS-730823 excreted in dialysate by the respective cumulative plasma AUC over the same dialysate collection interval (AUC(2-6) entering). CLD measurements occurred only in period 1. Geometric means were reported in milliliters per minute (mL/min).
Percentage of Apixaban Extracted During Hemodialysis
Time frame: 2 to 6 hours post-dose
The percentage of apixaban extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6) exiting - AUC(2-6) entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.
Percentage of BMS-730823 Extracted During Hemodialysis
Time frame: 2 to 6 hours post-dose
The percentage of BMS-730823 extracted during hemodialysis (extraction ratio) was calculated using the formula [plasma AUC(2-6)exiting - AUC(2-6)entering] / [AUC(2-6) entering] and converted to a percentage. The extraction ratio was measured in period 1 only, and was reported as a percentage.

4 secondary outcomes

Mean Maximum Percent Change From Baseline International Normalized Ratio (INR) Following a Single 5 mg Oral Dose of Apixaban
Time frame: From 24 hours pre-dose to 72 hours post-dose
Mean Maximum Percent Change From Baseline Prothrombin Time (PT) Following a Single 5 mg Oral Dose of Apixaban
Time frame: From 24 hours pre-dose to 72 hours post-dose
Mean Maximum Percent Change From Baseline Activated Partial Thromboplastin Time (aPTT) Following a Single Oral Dose of 5 mg Apixaban
Time frame: From 24 hours pre-dose to 72 hours post-dose
Mean Peak Anti-FXa Activity Following a Single Oral Dose of 5 mg Apixaban
Time frame: From 24 hours pre-dose to 72 hours post-dose

Results and safety

Results posted to the registry on 11 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Renal Function	8	8
ESRD Maintained With Hemodialysis	8	8

Primary outcome: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban

Time frame: 24 hours pre-dose to 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Normal Renal Function n = 8	ESRD Dose Before Hemodialysis n = 8	ESRD Dose After Hemodialysis n = 8
Value	125.6 (29)	98.9 (29)	113.6 (31)

Normal Renal Function vs ESRD Dose Before Hemodialysis: Geometric Mean Ratio: 0.787 (90% CI 0.616 to 1.006)
Normal Renal Function vs ESRD Dose After Hemodialysis: Geometric Mean Ratio: 0.904 (90% CI 0.697 to 1.173)
ESRD Dose Before Hemodialysis vs ESRD Dose After Hemodialysis: Geometric Mean Ratio: 0.871 (90% CI 0.723 to 1.049)

Population analysed: All treated participants

Primary outcome: Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Metabolite BMS-730823

Time frame: From 24 hours pre-dose to 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Normal Renal Function n = 8	ESRD Dose Before Hemodialysis n = 8	ESRD Dose After Hemodialysis n = 8
Value	10.8 (38)	15.9 (48)	20.0 (39)

Population analysed: All treated participants

Primary outcome: Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Single 5mg Oral Dose of Apixaban

Time frame: 24 hours pre-dose to 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Normal Renal Function n = 8	ESRD Dose Before Hemodialysis n = 8	ESRD Dose After Hemodialysis n = 8
Value	1205 (29)	1430 (41)	1673 (24)

Normal Renal Function vs ESRD Dose Before Hemodialysis: Geometric Mean Ratio: 1.187 (90% CI 0.907 to 1.553)
Normal Renal Function vs ESRD Dose After Hemodialysis: Geometric Mean Ratio: 1.389 (90% CI 1.097 to 1.758)
ESRD Dose Before Hemodialysis vs ESRD Dose After Hemodialysis: Geometric Mean Ratio: 0.855 (90% CI 0.707 to 1.033)

Population analysed: All treated participants

Primary outcome: Geometric Mean of Area Under the Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T)) of Metabolite BMS-730823

Time frame: From 24 hours pre-dose to 72 hours post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Normal Renal Function n = 8	ESRD Dose Before Hemodialysis n = 8	ESRD Dose After Hemodialysis n = 8
Value	205 (69)	746 (56)	953 (33)

Population analysed: All treated participants

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 until 30 days post discontinuation, up to September 2011 (approximately 3 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Renal Function	0 of 8 (0%)	0 of 8 (0%)	Not reported
ESRD Dose Before Hemodialysis	0 of 8 (0%)	2 of 8 (25%)	Not reported
ESRD Dose After Hemodialysis	0 of 8 (0%)	1 of 8 (12.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26331581Wang X, Tirucherai G, Marbury TC, Wang J, Chang M, Zhang D, Song Y, Pursley J, Boyd RA, Frost C. Pharmacokinetics, pharmacodynamics, and safety of apixaban in subjects with end-stage renal disease on hemodialysis. J Clin Pharmacol. 2016 May;56(5):628-36. doi: 10.1002/jcph.628. Epub 2015 Dec 22.

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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

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 Apixaban in people with End Stage Renal Disease, run by Bristol-Myers Squibb at 1 site in United States.

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 3 inclusion and 6 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 11 Oct 2016. 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 United States. 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 11 Oct 2016). 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?

Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Single 5mg Oral Dose of Apixaban (time frame: 24 hours pre-dose to 72 hours post-dose). The study lists 20 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 NCT01340586, which also lists 1 linked publication.

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 11 Oct 2016.