Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome

Completed · Phase 4

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Tumor Lysis Syndrome

In brief

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.

Key facts

Study ID

NCT04745910

Run by

M.D. Anderson Cancer Center

People needed

10

Starts

2022-04-05

Expected to finish

2026-04-27

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in the study, patients should fulfill the following criteria:
• Signed informed consent prior to any study specific procedures (patient or caregiver)
• Male or female 18 years of age or older
• In the investigator's opinion, expected survival of at least 1 month
• Deemed stable by the investigator
• Serum Uric Acid ≥ 6 mg/dL
• Risk for tumor lysis syndrome based on the MD Anderson TLS risk score

You may not qualify if…

• Patients will be ineligible for study enrollment if any of the following exclusion criteria are fulfilled:
• Inability or refusal to give informed consent (patient or caregiver)
• Subject unwilling to take study medication
• Known allergy to uricase
• Pregnant
• Breastfeeding
• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Transfusion in last 7 days (as this interferes with G6PD test), with the exception of platelet transfusions.
• Has received rasburicase during current admission.(Can be considered i24 hours after last Rasburicase administered, current or previous admission)

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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