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Also known as Drotrecogin alfa activated (Xigris)
Drotrecogin alfa activated · 1 trial · 1 indication
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
PTT level during a hemodialysis treatment will be used to assess the effectiveness of Xigris as an anticoagulant.
| Arm | Type | Description |
|---|---|---|
| Xigris | EXPERIMENTAL | Drotrecogin alfa activated (Xigris) used as anticoagulant in patients treated with hemodialysis. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: 1. \>18 2. Usually used heparin with HD Exclusion Criteria: 1. Plt \<100 2. Pregnancy 3. H/o bleeding diathesis 4. H/o CVA 5. Pt on Ticlid/plavix/warfarin 6. SBP \>200 7. BASELINE PTT\>50 8. INR\>1.6
Drotrecogin alfa activated was studied for use in patients with End Stage Renal Disease who are on hemodialysis. It is an investigational therapy in this nephrology setting and is not approved for this use. It was evaluated in a Phase 2 safety and dose finding study in hemodialysis patients.
Drotrecogin alfa activated targets coagulation factors F5 and F8. It acts as an inhibitor of these clotting proteins. By inhibiting F5 and F8, the drug affects the coagulation cascade, which is the biological pathway that drives blood clot formation.
Drotrecogin alfa activated is developed by Eli Lilly and Company, which trades under the ticker LLY. Eli Lilly sponsored the clinical research evaluating the drug in patients with End Stage Renal Disease undergoing hemodialysis.
Drotrecogin alfa activated is in Phase 2 development for End Stage Renal Disease. The single Phase 2 trial has been completed, and no trials are currently active. It remains an investigational agent and is not approved for this indication.
Drotrecogin alfa activated was studied in one completed Phase 2 trial, NCT01227187, titled Safety and Dose Finding Study of Xigris in Hemodialysis Patients. The trial enrolled 12 participants in the United States, was uncontrolled, and was not randomized or double blinded.
Yes, drotrecogin alfa activated is also known as Xigris. Xigris is the brand name under which Eli Lilly and Company developed and studied the drug. Searches for Xigris refer to the same molecule as drotrecogin alfa activated.