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Completed

NCT Number: NCT01227187

Safety and Dose Finding Study of Xigris in Hemodialysis Patients

The purpose of the study is to assess the safety of Xigris (Drotrecogin alfa) as an anticoagulant at different dose levels during dialysis treatment in patients with End Stage Renal Disease (ESRD).

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

About this study

In United States, there are over 300,000 patients with ESRD who require hemodialysis. Clinical hemodialysis takes place three times a week and is dependent on adequate anticoagulation throughout the three to four hour procedure. Infection is one of the most common causes of death for patients with ESRD treated with hemodialysis (25%).

Xigris (drotrecogin alfa activated) is a recombinant form of human activated protein C and is successfully used for treatment of adult patients with severe sepsis. In addition to its fibrinolytic properties, drotrecogin alpha has both an anti-inflammatory effect, and an anti-coagulant effect. However, there are few safety and no efficacy data on the effect of Xigris in ESRD patients as an anticoagulant.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18
  • Usually used heparin with HD

Exclusion criteria

  • Plt <100
  • Pregnancy
  • H/o bleeding diathesis
  • H/o CVA
  • Pt on Ticlid/plavix/warfarin
  • SBP >200
  • BASELINE PTT>50
  • INR>1.6

Treatment and study plan

Drotrecogin alfa activated (Xigris)

Drug

We will test different dose regimens of Drotrecogin alfa activated (Xigris) to determine the optimal dose to achieve PTT between 65 and 100 secs. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via pre-filter arterial drip chamber via a standard IV pump. The PTT will be assessed at baseline,15,30,60,120 and 180 mins. Xigris dose will be adjusted in the following patients if the afferent PTT rises above 100 secs (normal range 25-40 secs) or if PTT remains <65 secs. If PTT remains less than 65 secs, the dose will be increased to the second dose regiment of 18 mcg/kg/hr. The dose escalation will continue in increments of 6 mcg/kg/h to a maximum dose of 36 mcg/kg/h. Each patient will receive Xigris only once.

Other names: Drotrecogin alfa (activated)

Primary outcomes

  1. Mean Partial Thromboplastin Time (PTT) at 15 Minutes

    Time frame: PTT level at 15 minutes after start up of Xigris during the hemodialysis treatment.

    PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.

  2. Mean Partial Thromboplastin Time (PTT) at 30 Minutes

    Time frame: PTT level at 30 minutes after start up of Xigris during the hemodialysis treatment.

    PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.

  3. Mean Partial Thromboplastin Time (PTT) at 60 Minutes

    Time frame: PTT level at 60 minutes after start up of Xigris during the hemodialysis treatment.

    PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.

  4. Mean Partial Thromboplastin Time (PTT) at 120 Minutes

    Time frame: PTT level at 120 minutes after start up of Xigris during the hemodialysis treatment.

    PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.

  5. Mean Partial Thromboplastin Time (PTT) at 180 Minutes

    Time frame: PTT level at 180 minutes after start up of Xigris during the hemodialysis treatment.

    PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Safety and Dose Finding Study of Xigris (Drotrecogin Alfa Activated) as an Anti-coagulant in End Stage Renal Disease (ESRD) Patients Treated With Hemodialysis (HD)

Acronym: Xigris1003

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 25, 2010
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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