A Phase 4 interventional study of Pegloticase and Rasburicase in Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm and Tumor Lysis Syndrome, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by M.D. Anderson Cancer Center · Phase 4, Interventional, and Treatment
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.
PRIMARY OBJECTIVE:
I. To collect preliminary data on the effectiveness of a single dose of pegloticase in lowering serum uric acid levels to less than 6.0 mg/dl within 24 hours in patients with hyperuricemia in the setting of tumor lysis syndrome.
SECONDARY OBJECTIVES:
I. To assess the effect of pegloticase on renal function in patients with hyperuricemia in the setting of tumor lysis syndrome as measured by changes in serum creatinine/estimated glomerular filtration rate (eGFR) and urine output.
II. To estimate the rate of renal replacement therapy initiation for acute kidney injury secondary to tumor lysis syndrome among patients treated with pegloticase.
OUTLINE:
Patients receive pegloticase intravenously (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 once daily (QD) for 5 days.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 10 is below the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
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Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
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For inclusion in the study, patients should fulfill the following criteria:
Exclusion Criteria:
Patients will be ineligible for study enrollment if any of the following exclusion criteria are fulfilled:
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.
Drug: Pegloticase · Drug: Rasburicase
Given IV
Also known as: Des-(1-6)-(7-threonine,46-threonine,291-lysine,301-serine)uricase (EC 1.7.3.3, urate oxidase) Sus scrofa (pig) tetramer, Non Acetylated, Carbamates with alpha-carboxy-omega-methoxypoly(oxyethylene), Krystexxa, Methoxypolyethylene Glycol Uricase, Oxidase, Urate (Synthetic Sus scrofa variant pigks-DN subunit), homotetramer, amide with alpha-carboxy-omega-methoxypoly(oxy-1,2-ethanediyl), Polyethylene Glycol-uricase, Puricase
Given IV
Also known as: Elitek, Recombinant Urate Oxidase, SR 29142, SR-29142, Urate Oxidase
Response rate
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.
Time frame: Within 24 hours of single dose of pegloticase
Time from pegloticase infusion until serum uric acid levels drop to 6 mg/dL
Will display results in frequency tables and plots of serum uric acid levels across time.
Time frame: Up to 14 days after pegloticase administration
Renal function
Will summarize serum creatinine and estimated glomerular filtration rate at each time point and plot these lab values across time. Finally, will calculate the rate and 90% confidence interval for the initiation of renal replacement therapy within the 14-day observation window.
Time frame: Up to 14 days after pegloticase administration
Serum uric acid level
Will examine the association of baseline characteristics with serum uric acid level using the Fisher's exact test, student's t-test, paired t-test, Wilcoxon rank-sum test, or Wilcoxon signed-rank test and will employ graphical methods when useful.
Time frame: Up to 14 days after pegloticase administration
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center