At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Study of Rasburicase Administered by Two Different Schedules (Fixed Dosing vs. As Needed Dosing) in Patients at High Risk or Potential Risk for Tumor Lysis Syndrome
In Brief
A Phase 2 clinical trial evaluating As Needed Rasburicase and Fixed Dose Rasburicase for Tumor Lysis Syndrome. Completed, enrolled 82 participants across 1 site.
Detailed Summary
Primary Objectives: To determine the efficacy of rasburicase administered as a single dose followed by as needed dosing (investigational arm) as compared to fixed dosing for 5 days (standard treatment arm) in the treatment of patients at high risk or potential risk for tumor lysis syndrome. Secondary Objectives: 1. To evaluate the plasma uric acid area under the curve (AUC) from baseline through 7 days 2. To evaluate the incidence of renal insufficiency and electrolyte abnormalities. 3. To determine the safety and immunogenicity of rasburicase. 4. To evaluate the cost-effectiveness of the experimental treatment (investigational arm).
Study Details
Timeline
Interventions
.15 mg/kg IV Over 30 Minutes On Day 1. Day 2-5, once daily as needed.
.15 mg/kg IV Over 30 Minutes Daily