Trial · NCT00230178
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
NCT00230178, Phase 3, Completed, Sanofi; results first posted 2009-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome. Trials, record NCT00230178. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00230178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome
- NCT number
- NCT00230178
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 280 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Tumor Lysis Syndrome, Cancer, Hyperuricemia
- Interventions
- Rasburicase (SR29142), Allopurinol
- First posted
- 2005-09-30
- Last updated
- 2010-01-12
- Results first posted
- 2009-12-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Uric Acid Responder | Day 3 through Day 7 | Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 \<7.5 mg/dl. |
| Secondary | Plasma Uric Acid | Day 1 to Day 7 | Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values |
| Secondary | Time to Uric Acid Control | Day 1 to Day 7 | Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined \<=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Uric Acid Responder | Day 3 through Day 7 | Participants | NUMBER | |
| SECONDARY | Plasma Uric Acid | Day 1 to Day 7 | The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC. | mg*h/dL | MEAN |
| SECONDARY | Time to Uric Acid Control | Day 1 to Day 7 | The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug. | Hours | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Plasma Uric Acid Responder | Rasburicase | Responder | 80 | Participants | |
| Plasma Uric Acid Responder | Rasburicase + Allopurinol | Responder | 72 | Participants | |
| Plasma Uric Acid Responder | Allopurinol | Responder | 60 | Participants | |
| Plasma Uric Acid Responder | Rasburicase | Non-Responder | 12 | Participants | |
| Plasma Uric Acid Responder | Rasburicase + Allopurinol | Non-Responder | 20 | Participants | |
| Plasma Uric Acid Responder | Allopurinol | Non-Responder | 31 | Participants | |
| Plasma Uric Acid | Rasburicase | 77.25 | Standard Deviation 57.17 | mg*h/dL | |
| Plasma Uric Acid | Rasburicase + Allopurinol | 108.05 | Standard Deviation 70.49 | mg*h/dL | |
| Plasma Uric Acid | Allopurinol | 646.22 | Standard Deviation 285.29 | mg*h/dL | |
| Time to Uric Acid Control | Rasburicase | 4.1 | 95% Confidence Interval 4.0 to 4.5 | Hours |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rasburicase | 94 | |
| Overall Study | STARTED | Rasburicase + Allopurinol | 93 | |
| Overall Study | STARTED | Allopurinol | 93 | |
| Overall Study | Treated | Rasburicase | 92 | |
| Overall Study | Treated | Rasburicase + Allopurinol | 92 | |
| Overall Study | Treated | Allopurinol | 91 | |
| Overall Study | COMPLETED | Rasburicase | 90 | |
| Overall Study | COMPLETED | Rasburicase + Allopurinol | 86 | |
| Overall Study | COMPLETED | Allopurinol | 86 | |
| Overall Study | NOT COMPLETED | Rasburicase | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events639
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rasburicase | 51 | 92 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Rasburicase + Allopurinol | 49 | 92 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Allopurinol | 48 | 91 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rasburicase | 49 | 92 | |
| other | Neutropenia | Blood and lymphatic system disorders | Rasburicase + Allopurinol | 44 | 92 | |
| other | Neutropenia | Blood and lymphatic system disorders | Allopurinol | 45 | 91 | |
| other | Anaemia | Blood and lymphatic system disorders | Rasburicase | 31 | 92 | |
| other | Anaemia | Blood and lymphatic system disorders | Rasburicase + Allopurinol | 31 | 92 | |
| other | Anaemia | Blood and lymphatic system disorders | Allopurinol | 43 | 91 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Rasburicase | 19 | 92 |
1 to 10 of 639Source ClinicalTrials.gov
See all 639 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rasburicase | ||
| Total, all-cause mortality | Rasburicase + Allopurinol | ||
| Total, all-cause mortality | Allopurinol | ||
| Total, other adverse events | Rasburicase | 91 | 92 |
| Total, other adverse events | Rasburicase + Allopurinol | 92 | 92 |
| Total, other adverse events | Allopurinol | 90 | 91 |
| Total, serious adverse events | Rasburicase | 36 | 92 |
| Total, serious adverse events | Rasburicase + Allopurinol | 32 | 92 |
| Total, serious adverse events | Allopurinol | 29 | 91 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00230178
GET https://conductscience.org/api/trials/v1/NCT00230178/events?page=2