Rasburicase for Hyperuricemia - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00290992

Purpose

Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration.

Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.

Condition	Intervention	Phase
Nutritional and Metabolic Diseases	Drug: rasburicase (SR29142)	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-Label, Multi-Center Study of SR29142 as Uricolytic Therapy/Prophylaxis for Hyperuricemia in Pediatric Patients With Newly Diagnosed Hematological Malignancies at High Risk for Tumor Lysis Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Cancer Metabolic Disorders

Drug Information available for: Rasburicase

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Patients with a plasma uric acid level decreased to the endpoint by 48 hr after the start of first drug infusion and lasting until 24 hr after the start of final (Day 5) drug infusion.

Secondary Outcome Measures:

Safety will be assessed on clinical observation, laboratory test, vital sign (blood pressure, pulse rate and body temperature), and the occurrence of adverse events.
G6PD activity will be measured in only patients who demonstrate hemolysis.
Anti-SR29142 antibody and Anti-SCP antibody will be measured.
PK parameters.

Enrollment:	30
Study Start Date:	June 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

<18 years of age
Patient with newly diagnosed hematological malignancies presenting with hyperuricemia:
Uric acid > 7.5 mg/dL in patients ≥ 13 years old- Uric acid > 6.5mg/dL in patients <13 years old

Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined:

Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level,
Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following:
- At least one lymph node or mass >5 cm in diameter
- LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification
Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc.

Exclusion Criteria:

Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period.
Low birth weight infant (<2500g) or gestational age <37 weeks
Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period.
Known history of severe allergic reaction and/or severe asthma.
Known history or family history of glucose-6-phosphate dehydrogenase deficiency.
Known history of hemolysis and methemoglobinemia.
Severe disorders of liver or kidney. ALT (GPT) > 5.0 x ULN, Total Bilirubin > 3.0 x ULN, Creatinine > 3.0 x ULN
Uncontrollable infections (including viral infections).
Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. etc.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290992

Locations

Japan
Sanofi-Aventis
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Keiji OHNO

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Study director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00290992 History of Changes
Other Study ID Numbers:	ACT5080
Study First Received:	February 10, 2006
Last Updated:	March 27, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

urate oxidase, hyperuricemia, lymphoma, leukemia

Additional relevant MeSH terms:

Metabolic Diseases
Tumor Lysis Syndrome
Hyperuricemia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Pathologic Processes
Rasburicase
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012