Using pegloticase to lower uric acid in cancer patients with tumor lysis syndrome
Effect of Pegloticase on Reduction of Uric Acid in Patients With Tumor Lysis Syndrome: A Pilot Pragmatic Clinical Trial
This study is testing if a single dose of pegloticase can lower high uric acid levels in cancer patients with tumor lysis syndrome within 24 hours.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04745910 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of a single dose of pegloticase in reducing serum uric acid levels in patients experiencing hyperuricemia due to tumor lysis syndrome. The primary objective is to determine if pegloticase can lower uric acid levels to below 6.0 mg/dL within 24 hours. Secondary objectives include assessing the impact of pegloticase on renal function and the initiation rate of renal replacement therapy for acute kidney injury. Patients will receive pegloticase intravenously, with additional doses or standard care provided based on their response.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with hyperuricemia and a risk for tumor lysis syndrome.
Not a fit: Patients with known allergies to uricase or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce uric acid levels and improve kidney function in patients suffering from tumor lysis syndrome.
How similar studies have performed: Other studies have shown promise in using pegloticase for similar conditions, suggesting potential effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sreedhar Mandayam, MD — M.D. Anderson Cancer Center
- Study coordinator: Sreedhar Mandayam, MD
- Email: samandayam@mdanderson.org
- Phone: 713-745-8597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.