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Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00631579
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : October 2, 2009
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Brief Summary:

The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups.

Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.

Condition or disease Intervention/treatment Phase
Hyperuricemia Leukemia Lymphoma Drug: Rasburicase (SR29142) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Multicenter Study of Repeated Doses of SR29142 (Rasburicase) as a Uricolytic Therapy for Hyperuricemia in Adult Patients With Leukemia or Lymphoma.
Study Start Date : April 2003
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma
Drug Information available for: Rasburicase

Primary Outcome Measures :
  1. Safety via physical examination, laboratory tests and adverse events. Efficacy via plasma uric acid levels.

Secondary Outcome Measures :
  1. Pharmacokinetic parameters and anti-SR29142 antibodies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patient suffering from:

  • acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric acid level ; or
  • lymphoma,Stage ≥ III without regard to uric acid level; or
  • lymphomas, Stage II with bulky disease; or
  • lymphoma or leukemia, without regard to classification or morphology, with uric acid level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of normal (ULN).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00631579

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Tokyo, Japan
Sponsors and Collaborators
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Study Director: K.K. Sanofi
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Study Director, sanofi-aventis Identifier: NCT00631579    
Other Study ID Numbers: ARD5290
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
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Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Gout Suppressants
Antirheumatic Agents