Study of the Bioaccumulation of Tinzaparin in Renally Impaired Patients When Given at Prophylactic Doses
Status:
Completed
Trial end date:
2018-12-12
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess if accumulation of anti-Xa activity occurs after
repeated daily administration of prophylactic doses of tinzaparin in patients with severe
chronic kidney disease (CKD) requiring thromboprophylaxis for non-surgical conditions.
It is anticipated that tinzaparin used at a fixed dose for thromboprophylaxis in severe CKD
patients (eGFR ≤ 30 ml/min /1.73 m2) at risk for venous thromboembolism (VTE) will not
bioaccumulate at a significant level, meaning an increase of ≥ 20% of the anti-Xa mean level
between day 2 or 3 and day 5.