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

End-Stage Renal Disease Clinical Trial

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

Status Completed

Clinical Trial Summary

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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

• NCT number: NCT02289703
• Study type: Interventional
• Source: Janssen Research & Development, LLC
• Status: Completed
• Phase: Phase 1
• Start date: January 2015
• Completion date: March 2015