End-Stage Renal DiseasePhase 1NCT02289703

A Pharmacokinetics, Pharmacodynamics and Safety Study of Single Dose of Rivaroxaban in Participants With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis

A Phase 1 study testing Rivaroxaban 15 mg in people with End-Stage Renal Disease, run by Janssen Research & Development, LLC 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

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: End-Stage Renal Disease
What is being tested?: Rivaroxaban 15 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Mar 2015
Phase: Phase 1
Are there results?: None posted in the registry

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All Participants:
Body mass index (BMI = weight in kilogram [kg] divided by the square of height in meter [m]) between 18 and 38 kg/m^2, extremes included, and body weight not less than 50 kg
Additional Inclusion Criteria for ESRD Participants (Group A):
Participants with end-stage renal disease (ESRD) requiring maintenance hemodialysis 2 or 3 times a week for at least 3 months prior to Screening
Participants with clinically stable medical condition, consistent with ESRD, as judged by the investigator on the basis of the Screening physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and results of clinical laboratory tests performed within 3 weeks of the first administration of study drug (unless judged to be clinically unimportant by the investigator or sponsor)
Participants with diastolic blood pressure less than (<) 110 millimeter of mercury (mmHg) and/or systolic blood pressure <180 mmHg (at Screening only) recorded after 5 minutes rest in sitting position

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Additional Inclusion Criteria for Healthy Matched Control Participants (Group B):
Healthy Participants on the basis of Screening physical examination, medical history, vital signs, 12-lead ECG, and results of clinical laboratory tests performed within 3 weeks prior to the administration of study drug
Participants with diastolic blood pressure <95 mmHg and/or systolic blood pressure <150 mmHg recorded after 5 minutes rest in sitting position
Participants with normal renal function characterized as having creatinine clearance (CLcr) >80 mL/min by Cockcroft-Gault estimate

Who cannot join

Participants with history of clinically significant medical illness prior to Screening including (but not limited to) chronic atrial fibrillation, hemodynamically significant valvular heart disease, heart failure (New York Heart Association Class >=II) within 6 months prior to the Screening visit, cardiac revascularization within 6 months including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery, ischemic stroke within 6 months, previous intracranial hemorrhage at any time, anemia with a hemoglobin concentration <9 gram per deciliter (g/dL), or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Participants diagnosed with current malignancy/active disease; (however, participants with clinically stable prostate cancer, basal cell carcinoma of the skin or who have not required antineoplastic treatment of previous cancers for at least one year are eligible)
Participants with psychiatric disorders that would impair the participant's ability to participate or complete this study in the opinion of the investigator or the sponsor
Participants with history of gastrointestinal disease (for example, Crohn's disease) which could result in impaired absorption of the study drugs
Participants with any other disease or condition which could influence the physiological metabolic turnover of study drug (for example, endocrine diseases, febrile conditions, severe infections)
Participants with history of significant hemorrhage and gastrointestinal ulceration within 6 months prior to the screening visit

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Participants with known primary coagulation disorders (for example, von Willebrand's disease, hemophilias)
Participants with history of recurrent dialysis membrane thrombosis
Participants with sensitivity to heparin
Participants with dialysis for acute renal failure

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Knoxville, Tennessee

Other trials in United States

About this study

Official title: An Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis

The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and pharmacodynamics (the way a drug may change body function) of a single 15-milligram (mg) dose of rivaroxaban in both healthy participants with a creatinine clearance (CLcr) greater than equal to (>=) 80 milliliter per minute (mL/min) and clinically stable participants with end-stage renal disease (ESRD) on maintenance hemodialysis (a method used to remove waste material from the blood when the kidneys are unable to do so).

Read the detailed description

This is an open-label (participants and researchers are aware about the treatment, participants are receiving), single-dose, single-center, parallel group (a medical research study comparing the response in 2 or more groups of participants receiving different interventions) study. This study consists of a Screening Period (within 21 days prior to admission into the study center on Day -1), followed by 2 treatment periods for ESRD participants (Group A) (Treatment Period 1: rivaroxaban will be administered 2 hours before the start of a 4-hour hemodialysis session on Day 1; Treatment Period 2: rivaroxaban will be administered 3 hours after the completion of a 4-hour hemodialysis session on Day 1), or 1 treatment period for healthy participants (Group B) (single oral dose of rivaroxaban will be administered on Day 1). Each treatment period will have duration of 4 days. For ESRD participants, the 2 treatments periods will be separated by a washout period of at least 7 days and a maximum of 14 days. The total study duration for ESRD participants is approximately 43 days. The total study duration for healthy participants is approximately 25 days. Blood samples will be collected to assess pharmacokinetic and pharmacodynamic parameters. Participants' safety will be monitored throughout the study.

Conditions: End-Stage Renal Disease
Being tested: Rivaroxaban 15 mg
Keywords: End-Stage Renal Disease, Healthy, Rivaroxaban, BAY 59-7939, JNJ-39039039, Xarelto, Hemodialysis, Blood Coagulation, Pharmacokinetics
Medical subject headings: Kidney Failure, Chronic, Thrombosis

What participants receive

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

Rivaroxaban 15 mgDrug
Also called JNJ-39039039, BAY 59-7939, Xarelto
Single oral dose of rivaroxaban 15-mg tablet on Day 1 of each of the treatment periods.

Study groups in NCT02289703
Study group	Role	What they receive
Group A	Experimental	Participants with end-stage renal disease (ESRD), will receive a single 15-milligram (mg) oral dose of rivaroxaban in Treatment Period 1 on Day 1, administered 2 hours before the start of a 4-hour hemodialysis session followed 7 to 14 days later by Treatment Period 2 wherein a single 15-mg oral dose of rivaroxaban will be given 3 hours after the completion of a 4-hour hemodialysis session on Day 1. Receives: Drug: Rivaroxaban 15 mg
Group B	Experimental	Healthy control participants matching to 'Group A' participants, will receive a single 15-mg oral dose of rivaroxaban on Day 1. Receives: Drug: Rivaroxaban 15 mg

What is being measured

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

Maximum Observed Plasma Concentration (Cmax) of Rivaroxaban
The Cmax is the maximum observed plasma concentration.
Measured: Pre-dose up to 72 hrs post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUClast) of Rivaroxaban
The AUClast is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
Measured: Pre-dose up to 72 hrs post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Extrapolated Infinite Time (AUCinfinity) of Rivaroxaban
The AUCinfinity is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUClast and Clast/lambda(z), where AUClast is area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.
Measured: Pre-dose up to 72 hrs post-dose

Secondary outcomes (3)

Maximum Observed Effect (Emax) for Prothrombin Time (PT), Factor Xa (FXa) Inhibition and Anti-FXa
Maximum observed effect (Emax) for parameters: prothrombin time (PT), factor Xa (FXa) inhibition and anti-FXa, will be assessed.
Measured: Pre-dose up to 72 hrs post-dose
Area Under the Dose-Response Curve for Prothrombin Time (PT), Factor Xa (FXa) Inhibition and Anti-FXa
The area under the dose-response curve for parameters: prothrombin time, FXa inhibition and anti-FXa, will be assessed.
Measured: Pre-dose up to 72 hrs post-dose
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Screening up to end of study (Group A: maximum up to 43 days, Group B: maximum up to 25 days) or up to early withdrawal

Timeline

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

Jan 2015Mar 2015

First posted13 Nov 2014 (estimated)
Study startJan 2015
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02289703
Sponsor's protocol ID: CR105711
Other IDs: RIVAROXCRF1001
Status last verified: Jan 2017
First submitted: 10 Nov 2014
Last updated: 24 Jan 2017
Results posted: No
Data monitoring committee: No

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 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis
ClinicalTrials.gov ID: NCT02289703
Acronym / sponsor ID: CR105711
Conditions: End-Stage Renal Disease
Keywords: End-Stage Renal Disease, Healthy, Rivaroxaban, BAY 59-7939, JNJ-39039039, Xarelto, Hemodialysis, Blood Coagulation
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Collaborators: Bayer
Study start: Jan 2015
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 13 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Group A	Experimental	Drug: Rivaroxaban 15 mgParticipants with end-stage renal disease (ESRD), will receive a single 15-milligram (mg) oral dose of rivaroxaban in Treatment Period 1 on Day 1, administered 2 hours before the start of a 4-hour hemodialysis session followed 7 to 14 days later by Treatment Period 2 wherein a single 15-mg oral dose of rivaroxaban will be given 3 hours after the completion of a 4-hour hemodialysis session on Day 1.
Group B	Experimental	Drug: Rivaroxaban 15 mgHealthy control participants matching to 'Group A' participants, will receive a single 15-mg oral dose of rivaroxaban on Day 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

All Participants:
Body mass index (BMI = weight in kilogram [kg] divided by the square of height in meter [m]) between 18 and 38 kg/m^2, extremes included, and body weight not less than 50 kg
Additional Inclusion Criteria for ESRD Participants (Group A):
Participants with end-stage renal disease (ESRD) requiring maintenance hemodialysis 2 or 3 times a week for at least 3 months prior to Screening
Participants with clinically stable medical condition, consistent with ESRD, as judged by the investigator on the basis of the Screening physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and results of clinical laboratory tests performed within 3 weeks of the first administration of study drug (unless judged to be clinically unimportant by the investigator or sponsor)

Key exclusion criteria (10 listed)

Participants with history of clinically significant medical illness prior to Screening including (but not limited to) chronic atrial fibrillation, hemodynamically significant valvular heart disease, heart failure (New York Heart Association Class >=II) within 6 months prior to the Screening visit, cardiac revascularization within 6 months including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery, ischemic stroke within 6 months, previous intracranial hemorrhage at any time, anemia with a hemoglobin concentration <9 gram per deciliter (g/dL), or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
Participants diagnosed with current malignancy/active disease; (however, participants with clinically stable prostate cancer, basal cell carcinoma of the skin or who have not required antineoplastic treatment of previous cancers for at least one year are eligible)
Participants with psychiatric disorders that would impair the participant's ability to participate or complete this study in the opinion of the investigator or the sponsor
Participants with history of gastrointestinal disease (for example, Crohn's disease) which could result in impaired absorption of the study drugs
Participants with any other disease or condition which could influence the physiological metabolic turnover of study drug (for example, endocrine diseases, febrile conditions, severe infections)

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
Rivaroxaban 15 mgAlso: JNJ-39039039, BAY 59-7939, XareltoSingle oral dose of rivaroxaban 15-mg tablet on Day 1 of each of the treatment periods.	Drug	Group A, Group B

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Rivaroxaban
Time frame: Pre-dose up to 72 hrs post-dose
The Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to Last Quantifiable Time (AUClast) of Rivaroxaban
Time frame: Pre-dose up to 72 hrs post-dose
The AUClast is the area under the plasma concentration-time curve from time zero to time of last quantifiable concentration.
Area Under the Plasma Concentration-time Curve From Time Zero to Extrapolated Infinite Time (AUCinfinity) of Rivaroxaban
Time frame: Pre-dose up to 72 hrs post-dose
The AUCinfinity is the area under the plasma concentration-time curve from time zero to extrapolated infinite time, calculated as the sum of AUClast and Clast/lambda(z), where AUClast is area under the plasma concentration-time curve from time zero to time of last quantifiable plasma concentration; Clast is the last observed quantifiable concentration; and lambda(z) is first-order rate constant associated with the terminal portion of the semilogarithmic drug concentration-time curve.

3 secondary outcomes

Maximum Observed Effect (Emax) for Prothrombin Time (PT), Factor Xa (FXa) Inhibition and Anti-FXa
Time frame: Pre-dose up to 72 hrs post-dose
Area Under the Dose-Response Curve for Prothrombin Time (PT), Factor Xa (FXa) Inhibition and Anti-FXa
Time frame: Pre-dose up to 72 hrs post-dose
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Screening up to end of study (Group A: maximum up to 43 days, Group B: maximum up to 25 days) or up to early withdrawal

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
An Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects with End-Stage Renal Disease (ESRD) on Maintenance HemodialysisLink 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.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

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 Rivaroxaban 15 mg in people with End-Stage Renal Disease, run by Janssen Research & Development, LLC 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 10 inclusion and 10 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 24 Jan 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Observed Plasma Concentration (Cmax) of Rivaroxaban (time frame: Pre-dose up to 72 hrs post-dose). 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 NCT02289703.

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 24 Jan 2017.