Clinical trial · Interventional
Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome
Effect of Pegloticase on Reduction of Uric Acid in Patients With Tumor Lysis Syndrome: A Pilot Pragmatic Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic and Lymphoid Cell Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Tumor Lysis Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegloticase | Drug | — | UNRESOLVED |
| Rasburicase | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (pegloticase)
- description
- Patients receive pegloticase IV over 120 minutes. Patients whose serum uric acid does not drop below 6 mg/dL within 24 hours receive a second dose of pegloticase IV over 120 minutes on day 2. Patients whose serum uric acid does not drop below 6 mg/dL after two doses of pegloticase receive standard of care rasburicase IV QD for 5 days.
- interventionNames
- Drug: Pegloticase
- Drug: Rasburicase
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Within 24 hours of single dose of pegloticase
- description
- Will estimate the 24-hour response rate along with the corresponding 90% confidence interval. In addition, the report will present plots of uric acid levels across all time points.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: 1. Signed informed consent prior to any study specific procedures (patient or caregiver) 2. Male or female 18 years of age or older 3. In the investigator's opinion, expected survival of at least 1 month 4. Deemed stable by the investigator 5. Serum Uric Acid ≥ 6 mg/dL 6. Risk for tumor lysis syndrome based on the MD Anderson TLS risk score Exclusion Criteria: Patients will be ineligible for study enrollment if any of the following exclusion criteria are fulfilled: 1. Inability or refusal to give informed consent (patient or caregiver) 2. Subject unwilling to take study medication 3. Known allergy to uricase 4. Pregnant 5. Breastfeeding 6. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 7. Transfusion in last 7 days (as this interferes with G6PD test), with the exception of platelet transfusions. 8. Has received rasburicase during current admission.(Can be considered i24 hours after last Rasburicase administered, current or previous admission)
References
Publications (0)
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