Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome (NCT04745910) | Clinical Trial Compass
CompletedPhase 4
Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome
United States10 participantsStarted 2022-04-05
Plain-language summary
This trial studies the effect of pegloticase in reducing uric acid levels in patients with hyperuricemia (high blood levels of uric acid) caused by tumor lysis syndrome. Tumor lysis syndrome occurs when the breakdown products of cancer cells, such as uric acid, enter the blood stream. High levels of uric acid in blood may cause kidney damage and reduce kidney function. The goal of this trial is to learn if pegloticase may lower uric acid levels in blood when given to cancer patients with hyperuricemia caused by tumor lysis syndrome.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Signed informed consent prior to any study specific procedures (patient or caregiver)
ā. Male or female 18 years of age or older
ā. In the investigator's opinion, expected survival of at least 1 month
ā. Deemed stable by the investigator
ā. Serum Uric Acid ā„ 6 mg/dL
ā. Risk for tumor lysis syndrome based on the MD Anderson TLS risk score
Exclusion criteria
ā. Inability or refusal to give informed consent (patient or caregiver)
ā. Subject unwilling to take study medication
ā. Known allergy to uricase
ā. Pregnant
ā. Breastfeeding
What they're measuring
1
Response rate
Timeframe: Within 24 hours of single dose of pegloticase
. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
ā. Transfusion in last 7 days (as this interferes with G6PD test), with the exception of platelet transfusions.
ā. Has received rasburicase during current admission.(Can be considered i24 hours after last Rasburicase administered, current or previous admission)