check_circleStudy Completed

Thromboembolic disorders

Bayer Identifier:

12890

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

2014-003913-27

EU CT Number:

Not Available
BAY59-7939, Dialysis Heamofiltration Study

Trial purpose

The main objective of the study was to investigate the effect of hemodialysis on the pharmacokinetics (PK) maximum observed drug concentration in measured matrix after single dose administration (Cmax), Cmax divided by dose per body weight (Cmax,norm), area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) and AUC divided by dose per body weight (AUCnorm)) of rivaroxaban (Xarelto / BAY59-7939) in subjects with end-stage renal disease (ESRD) on hemodialysis and age-, body weight-, and gender-matched healthy volunteers.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years
  • -

  • -

Trial summary

Enrollment Goal
32
Trial Dates
June 2015 - March 2017
Phase
Phase 1
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Kiel, 24105, Germany

Primary Outcome

  • Maximum Observed Drug Concentration (Cmax) of Rivaroxaban After Single Dose Administration in Plasma
    Maximum observed drug concentration of rivaroxaban after single dose administration in plasma was measured.
    date_rangeTime Frame:
    Pre-dose (0 hours) to 72 hours post-dose
  • Maximum Observed Drug Concentration Divided by Dose per Body Weight (Cmax,norm) of Rivaroxaban After Single Dose Administration in Plasma
    Maximum observed drug concentration divided by dose per body weight of rivaroxaban after single dose administration in plasma was measured.
    date_rangeTime Frame:
    Pre-dose (0 hours) to 72 hours post-dose
  • Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC) of Rivaroxaban After Single Dose Administration in Plasma
    Area under the concentration versus time curve from zero to infinity of rivaroxaban after single dose administration in plasma was measured.
    date_rangeTime Frame:
    Pre-dose (0 hours) to 72 hours post-dose
  • Area Under the Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Body Weight (AUCnorm) of Rivaroxaban After Single Dose Administration in Plasma
    Area under the concentration versus time curve from zero to infinity divided by dose per body weight of rivaroxaban after single dose administration in plasma was measured.
    date_rangeTime Frame:
    Pre-dose (0 hours) to 72 hours post-dose

Secondary Outcome

  • Number of Subjects with Semi Quantitative Clotting Scores (SQCS)
    Anticoagulation efficacy was assessed by SQCS. Clotting scores were assigned as follows: score 0-clean filter and no visible clots in the drip chambers; score 1-for traces of coagulation in the filter and/or in the drip chambers; score 2-intermediate state between “1” and “3”; score 3-fully clotted extra-corporal system resulting in an interruption of the hemodialysis session. Adequate anticoagulation was defined by a SQCS of less or equal “1”.
    date_rangeTime Frame:
    Immediately after hemodialysis on Day 0 at 7 hour

Trial design

Single dose, randomized, parallel-group study to investigate the pharmacokinetics and pharmacodynamics of rivaroxaban in patients undergoing hemodialysis in comparison to age-and gender-matched healthy volunteers
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
Open Label
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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