Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 is an investigational small molecule being studied for End Stage Renal Disease. It is in Phase 2 clinical development, with one completed trial in hemodialysis patients. The drug is not approved and remains under investigation for this condition.
Drotrecogin alfa activated is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY. The company conducted a Phase 2 study of the drug in patients with End Stage Renal Disease.
Drotrecogin alfa activated is in Phase 2 clinical development. A single Phase 2 trial, NCT01227187, has been completed in the United States. The drug is investigational and has not been approved for any use.
Drotrecogin alfa activated has one completed clinical trial, NCT01227187, titled 'Safety and Dose Finding Study of Xigris in Hemodialysis Patients.' This Phase 2 study enrolled 12 participants with End Stage Renal Disease in the United States.
Yes, Drotrecogin alfa activated is also known as Xigris. The completed clinical trial NCT01227187 is titled 'Safety and Dose Finding Study of Xigris in Hemodialysis Patients,' confirming the alternative name for this drug.