Chronic Renal FailurePhase 4NCT02047006

Dose-finding of Rivaroxaban in Hemodialysis

A Phase 4 study testing Rivaroxaban 10 mg in people with Chronic Renal Failure, run by AZ Sint-Jan AV at 2 sites in Belgium.

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

Rivaroxaban is a recently developed factor Xa (FXa) inhibitor for the prevention and treatment of thromboembolic disease. There are no data on dose adjustments in patients with severe chronic renal failure. It's use is therefore not recommended in this patient population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Renal Failure
What is being tested?: Rivaroxaban 10 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 2 sitesBelgium
Study dates: Sep 2013to Oct 2014
Phase: Phase 4
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
No healthy volunteers
Adult, Older adult

Who may be able to join

age ≥18 year
signed informed consent
chronic hemodialysis patients without immediate life-threatening conditions, dialysed three times a week for at least three months
requiring anticoagulation for the prevention of deep venous thrombosis

Who cannot join

residual renal function, as defined by a residual diuresis of >50 ml/day
known intestinal malabsorption
inability to take oral medication
mechanical heart valve
inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir)
severe liver dysfunction Child-Pugh grade C

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

OLV Aalst
Aalst, 9300
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000

Other trials in Belgium

About this study

Official title: Finding the Optimal Dose of Rivaroxaban in Hemodialysis Patients

the AUC and Cmax of 10 mg rivaroxaban
the effect of 10 mg rivaroxaban on coagulation assays
the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa levels
the safety and tolerability of rivaroxaban

Read the detailed description

Background and Rationale: Vitamin K antagonists have been the standard anticoagulant treatment for decades, despite their unpredictable pharmacology and their slow onset and offset of action, requiring frequent monitoring and bridging with low molecular weight heparins (LMWH), and resulting in a substantial risk of under- and overtreatment. Patients with end-stage renal disease have an increased risk of bleeding due to their underlying disease. Therefore, anticoagulants need to be used with caution in these patients. In addition, the vitamin K antagonists are increasingly implicated in the development of vascular calcifications in this already vulnerable population. A search for alternative anticoagulants is therefore warranted. Rivaroxaban is a recently developed factor Xa (FXa) inhibitor for the prevention and treatment of thromboembolic disease (1). Rivaroxaban has a much lower pharmacokinetic variability and little interaction with food and drugs, contributing to consistent and predictable anticoagulation. As a consequence, routine monitoring is not required. Rivaroxaban has been shown to be effective and safe in large trials on the prevention and treatment of venous thromboembolism (2,3) and the prevention of stroke in atrial fibrillation (4). Rivaroxaban inhibits factor Xa in a concentration-dependent manner. Even though routine monitoring is not required, there are clinical situations in which an evaluation of its anticoagulant effect is desirable. Rivaroxaban prolongs prothrombin time (PT) and activated partial thromboplastin time (aPTTT) in a concentration-dependent manner. However, the extent of prolongation varies considerably with the type of reagent that is used. This variation cannot be reduced by conversion of PT values given in seconds to international normalized ratio values; therefore, PT and activated partial thromboplastin time are not useful for measuring the pharmacodynamic effects of rivaroxaban. Anti- Factor Xa activity is also influenced by rivaroxaban and is the most reliable method to evaluate the clinical effect of rivaroxaban (5). The absolute bioavailability of rivaroxaban is high (80 % - 100 %) for the 10 mg dose, with maximum plasma concentration (Cmax). appearing 2 - 4 hours after tablet intake. Intake with food does not affect rivaroxaban area under the curve (AUC) or Cmax. Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily. Plasma protein binding in humans is high at approximately 92 % to 95 %, with serum albumin being the main binding component. Due to the high plasma protein binding rivaroxaban is not expected to be dialysable. There are, however, no data about plasma protein binding in hemodialysis patients. Unchanged rivaroxaban is the most important compound in human plasma, with no major or active circulating metabolites being present. With a systemic clearance of about 10 l/h, rivaroxaban can be classified as a low-clearance drug. After intravenous administration of a 1 mg dose the elimination half-life is about 4.5 hours. After oral administration of a 10 mg dose the elimination becomes absorption rate limited with mean terminal half-lives of 7 to 11 hours (6,7). Rivaroxaban has a dual mode of elimination. Approximately 2/3 of the administered dose is metabolized to inactive metabolites in the liver, with half then being eliminated renally and the other half eliminated by the faecal route. The final 1/3 of the administered dose undergoes direct renal excretion as unchanged active substance in the urine, mainly via active renal secretion (6,7). In individuals with mild (measured creatinine clearance [CreaCl] 50-80 ml/min), moderate (CreaCl 30-49 ml/min) and severe (CreaCl 15-29 ml/min) renal impairment, rivaroxaban plasma concentrations (AUC) were increased 1.4-, 1.5- and 1.6-fold respectively, as compared with control subjects, whereas maximum plasma concentration was relatively unaffected (8). Corresponding increases in pharmacodynamic effects were more pronounced. In individuals with mild, moderate and severe renal impairment the overall inhibition of factor Xa-activity was increased by a factor of 1.5, 1.9 and 2.0 respectively, as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 1.3, 2.2 and 2.4 respectively (8). There are no data in patients with CreaCl < 15 ml/min. Based on these data, dosing guidelines for patients with renal failure have been issued. No dose adjustment is necessary in patients with mild renal impairment (CreaCl 50-80 ml/min) or moderate renal impairment (CreaCl 30-49 ml/min). In patients with severe renal impairment (CreaCl 15-29 ml/min), rivaroxaban is to be used with caution. Use is not recommended in patients with CreaCl < 15 ml/min (6,7).
Study design A two-centre, non-blinded cohort study.
Study objectives 1) To measure the AUC and Cmax of 10 mg rivaroxaban in hemodialysis patients 2) To assess the effect of 10 mg rivaroxaban on coagulation assays in hemodialysis patients:

anti-Xa assay
prothrombin assay 3) To assess the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa levels 4) To assess safety and tolerability of rivaroxaban in hemodialysis patients

Study subjects
Enrolment procedure The study protocol will be discussed with eligible patients. All patients under treatment in the participating centers that meet the in- and exclusion criteria that give informed consent will be included.
Planned number of participants 12 patients
Inclusion criteria

age ≥18 year
signed informed consent
chronic hemodialysis patients without immediate life-threatening conditions, dialysed three times a week for at least three months
requiring anticoagulation for the prevention of deep venous thrombosis

Exclusion criteria

residual renal function, as defined by a residual diuresis of >50 ml/day
known intestinal malabsorption
inability to take oral medication
mechanical heart valve
inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir)
severe liver dysfunction Child-Pugh grade C

Conditions: Chronic Renal Failure
Being tested: Rivaroxaban 10 mg
Keywords: Hemodialysis, Rivaroxaban, AUC
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.

Rivaroxaban 10 mgDrug
Measurement of AUC of rivaroxaban and effect on coagulation assays:
Venous blood samples (8.5 ml) are collected immediately before (t=0) and at t= 0,5, 1, 2, 4, 8, 12, 24, 36 and 44 hours after administration of rivaroxaban.
Effect of dialysis on levels of rivaroxaban:
Venous blood samples (8.5 ml) are collected at the start of dialysis (t=0) and at t=1, 2, 3 and 4 hours.

Study groups in NCT02047006
Study group	Role	What they receive
Rivaroxaban 10 mg	Experimental	Measurement of AUC of rivaroxaban and effect on coagulation assays: Rivaroxaban is given as a single oral dose of 10 mg immediately after three subsequent dialysis sessions. Patients remain in the hospital from the intake of the first dose until 48 hours after the intake of the third dose. Effect of dialysis on levels of rivaroxaban: Rivaroxaban is given as a single oral dose of 10 mg in the morning when dialysis is scheduled in the afternoon, or the previous evening when dialysis is scheduled in the morning. The interval between the two doses was at least 48 hours. Dialysis is scheduled 6 to 8 hours after the intake of rivaroxaban. Receives: Drug: Rivaroxaban 10 mg

What is being measured

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

Pharmacokinetics and pharmacodynamics of rivaroxaban in hemodialysis patients
1. To measure the AUC and Cmax of 10 mg rivaroxaban in hemodialysis patients
2. To assess the effect of 10 mg rivaroxaban on coagulation assays in hemodialysis patients:
- anti-Xa assay
- prothrombin assay
Measured: AUC for 48 hours

Secondary outcomes (2)

Dialytic removal of rivaroxaban
To assess the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa levels
Measured: 4 hours
Safety and tolerability of rivaroxaban in hemodialysis patients
Subjective tolerability is evaluated by questioning the patients about any adverse events or by spontaneous reporting of adverse events. Objective tolerability is evaluated by monitoring vital signs and routine clinical laboratory tests.
Measured: 2 weeks

Timeline

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

Sep 2013Oct 2014

First posted28 Jan 2014 (estimated)
Study startSep 2013
Primary completionFeb 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02047006
Sponsor's protocol ID: 2013-Nephrology-ADV
Status last verified: Jan 2015
First submitted: 24 Jan 2014
Last updated: 14 Jan 2015
Results posted: No
Data monitoring committee: Yes

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 Chronic Renal Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Finding the Optimal Dose of Rivaroxaban in Hemodialysis Patients
ClinicalTrials.gov ID: NCT02047006
Acronym / sponsor ID: 2013-Nephrology-ADV
Conditions: Chronic Renal Failure
Keywords: Hemodialysis, Rivaroxaban, AUC
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: AZ Sint-Jan AVUniversity, hospital or other
Collaborators: Onze Lieve Vrouw Hospital
Study start: Sep 2013
Primary completion: Feb 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 28 Jan 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.

the AUC and Cmax of 10 mg rivaroxaban
the effect of 10 mg rivaroxaban on coagulation assays
the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa levels
the safety and tolerability of rivaroxaban

Detailed description

Background and Rationale: Vitamin K antagonists have been the standard anticoagulant treatment for decades, despite their unpredictable pharmacology and their slow onset and offset of action, requiring frequent monitoring and bridging with low molecular weight heparins (LMWH), and resulting in a substantial risk of under- and overtreatment. Patients with end-stage renal disease have an increased risk of bleeding due to their underlying disease. Therefore, anticoagulants need to be used with caution in these patients. In addition, the vitamin K antagonists are increasingly implicated in the development of vascular calcifications in this already vulnerable population. A search for alternative anticoagulants is therefore warranted. Rivaroxaban is a recently developed factor Xa (FXa) inhibitor for the prevention and treatment of thromboembolic disease (1). Rivaroxaban has a much lower pharmacokinetic variability and little interaction with food and drugs, contributing to consistent and predictable anticoagulation. As a consequence, routine monitoring is not required. Rivaroxaban has been shown to be effective and safe in large trials on the prevention and treatment of venous thromboembolism (2,3) and the prevention of stroke in atrial fibrillation (4). Rivaroxaban inhibits factor Xa in a concentration-dependent manner. Even though routine monitoring is not required, there are clinical situations in which an evaluation of its anticoagulant effect is desirable. Rivaroxaban prolongs prothrombin time (PT) and activated partial thromboplastin time (aPTTT) in a concentration-dependent manner. However, the extent of prolongation varies considerably with the type of reagent that is used. This variation cannot be reduced by conversion of PT values given in seconds to international normalized ratio values; therefore, PT and activated partial thromboplastin time are not useful for measuring the pharmacodynamic effects of rivaroxaban. Anti- Factor Xa activity is also influenced by rivaroxaban and is the most reliable method to evaluate the clinical effect of rivaroxaban (5). The absolute bioavailability of rivaroxaban is high (80 % - 100 %) for the 10 mg dose, with maximum plasma concentration (Cmax). appearing 2 - 4 hours after tablet intake. Intake with food does not affect rivaroxaban area under the curve (AUC) or Cmax. Rivaroxaban pharmacokinetics are approximately linear up to about 15 mg once daily. Plasma protein binding in humans is high at approximately 92 % to 95 %, with serum albumin being the main binding component. Due to the high plasma protein binding rivaroxaban is not expected to be dialysable. There are, however, no data about plasma protein binding in hemodialysis patients. Unchanged rivaroxaban is the most important compound in human plasma, with no major or active circulating metabolites being present. With a systemic clearance of about 10 l/h, rivaroxaban can be classified as a low-clearance drug. After intravenous administration of a 1 mg dose the elimination half-life is about 4.5 hours. After oral administration of a 10 mg dose the elimination becomes absorption rate limited with mean terminal half-lives of 7 to 11 hours (6,7). Rivaroxaban has a dual mode of elimination. Approximately 2/3 of the administered dose is metabolized to inactive metabolites in the liver, with half then being eliminated renally and the other half eliminated by the faecal route. The final 1/3 of the administered dose undergoes direct renal excretion as unchanged active substance in the urine, mainly via active renal secretion (6,7). In individuals with mild (measured creatinine clearance [CreaCl] 50-80 ml/min), moderate (CreaCl 30-49 ml/min) and severe (CreaCl 15-29 ml/min) renal impairment, rivaroxaban plasma concentrations (AUC) were increased 1.4-, 1.5- and 1.6-fold respectively, as compared with control subjects, whereas maximum plasma concentration was relatively unaffected (8). Corresponding increases in pharmacodynamic effects were more pronounced. In individuals with mild, moderate and severe renal impairment the overall inhibition of factor Xa-activity was increased by a factor of 1.5, 1.9 and 2.0 respectively, as compared to healthy volunteers; prolongation of PT was similarly increased by a factor of 1.3, 2.2 and 2.4 respectively (8). There are no data in patients with CreaCl < 15 ml/min. Based on these data, dosing guidelines for patients with renal failure have been issued. No dose adjustment is necessary in patients with mild renal impairment (CreaCl 50-80 ml/min) or moderate renal impairment (CreaCl 30-49 ml/min). In patients with severe renal impairment (CreaCl 15-29 ml/min), rivaroxaban is to be used with caution. Use is not recommended in patients with CreaCl < 15 ml/min (6,7).
Study design A two-centre, non-blinded cohort study.
Study objectives 1) To measure the AUC and Cmax of 10 mg rivaroxaban in hemodialysis patients 2) To assess the effect of 10 mg rivaroxaban on coagulation assays in hemodialysis patients:

anti-Xa assay
prothrombin assay 3) To assess the effect of a single dialysis session on plasma levels of rivaroxaban and on anti-Xa levels 4) To assess safety and tolerability of rivaroxaban in hemodialysis patients

Study subjects
Enrolment procedure The study protocol will be discussed with eligible patients. All patients under treatment in the participating centers that meet the in- and exclusion criteria that give informed consent will be included.
Planned number of participants 12 patients
Inclusion criteria

age ≥18 year
signed informed consent
chronic hemodialysis patients without immediate life-threatening conditions, dialysed three times a week for at least three months
requiring anticoagulation for the prevention of deep venous thrombosis

Exclusion criteria

residual renal function, as defined by a residual diuresis of >50 ml/day
known intestinal malabsorption
inability to take oral medication
mechanical heart valve
inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir)
severe liver dysfunction Child-Pugh grade C

Study design

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

Arm	Type	Receives
Rivaroxaban 10 mg	Experimental	Drug: Rivaroxaban 10 mgMeasurement of AUC of rivaroxaban and effect on coagulation assays: Rivaroxaban is given as a single oral dose of 10 mg immediately after three subsequent dialysis sessions. Patients remain in the hospital from the intake of the first dose until 48 hours after the intake of the third dose. Effect of dialysis on levels of rivaroxaban: Rivaroxaban is given as a single oral dose of 10 mg in the morning when dialysis is scheduled in the afternoon, or the previous evening when dialysis is scheduled in the morning. The interval between the two doses was at least 48 hours. Dialysis is scheduled 6 to 8 hours after the intake of rivaroxaban.

Who may qualify

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

Key inclusion criteria (4 listed)

age ≥18 year
signed informed consent
chronic hemodialysis patients without immediate life-threatening conditions, dialysed three times a week for at least three months
requiring anticoagulation for the prevention of deep venous thrombosis

Key exclusion criteria (6 listed)

residual renal function, as defined by a residual diuresis of >50 ml/day
known intestinal malabsorption
inability to take oral medication
mechanical heart valve
inability to stop co-medication that causes major interactions with rivaroxaban (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir)

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 10 mgMeasurement of AUC of rivaroxaban and effect on coagulation assays: Venous blood samples (8.5 ml) are collected immediately before (t=0) and at t= 0,5, 1, 2, 4, 8, 12, 24, 36 and 44 hours after administration of rivaroxaban. Effect of dialysis on levels of rivaroxaban: Venous blood samples (8.5 ml) are collected at the start of dialysis (t=0) and at t=1, 2, 3 and 4 hours.	Drug	Rivaroxaban 10 mg

Primary outcome

Pharmacokinetics and pharmacodynamics of rivaroxaban in hemodialysis patients
Time frame: AUC for 48 hours
1. To measure the AUC and Cmax of 10 mg rivaroxaban in hemodialysis patients 2. To assess the effect of 10 mg rivaroxaban on coagulation assays in hemodialysis patients: * anti-Xa assay * prothrombin assay

2 secondary outcomes

Dialytic removal of rivaroxaban
Time frame: 4 hours
Safety and tolerability of rivaroxaban in hemodialysis patients
Time frame: 2 weeks

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 14 Jan 2015.

Related trials for Chronic Renal Failure

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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.

An S De Vriese, MD, PhD principal investigator

AZ Sint-Lucas Brugge

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Rivaroxaban 10 mg in people with Chronic Renal Failure, run by AZ Sint-Jan AV at 2 sites in Belgium.

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 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 14 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 2 sites in Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Pharmacokinetics and pharmacodynamics of rivaroxaban in hemodialysis patients (time frame: AUC for 48 hours). 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 NCT02047006.

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 14 Jan 2015.