Trial Condition(s):
Thromboembolic disorders
BAY59-7939, Dialysis Heamofiltration Study
Bayer Identifier:
12890
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Maximum Observed Drug Concentration (Cmax) of Rivaroxaban After Single Dose Administration in PlasmaMaximum observed drug concentration of rivaroxaban after single dose administration in plasma was measured.Timeframe: 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 PlasmaMaximum observed drug concentration divided by dose per body weight of rivaroxaban after single dose administration in plasma was measured.Timeframe: 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 PlasmaArea under the concentration versus time curve from zero to infinity of rivaroxaban after single dose administration in plasma was measured.Timeframe: 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 PlasmaArea 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.Timeframe: 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”.Timeframe: Immediately after hemodialysis on Day 0 at 7 hour
Additional Information
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