Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00230178

First received: September 28, 2005

Last updated: January 8, 2010

Last verified: January 2010

History of Changes

Results First Received: July 22, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Tumor Lysis Syndrome Cancer Hyperuricemia
Interventions:	Drug: Rasburicase (SR29142) Drug: Allopurinol

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Rasburicase	Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
Rasburicase + Allopurinol	Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
Allopurinol	Allopurinol (300 mg/day) given alone as a single agent for 5 days

Participant Flow: Overall Study

	Rasburicase	Rasburicase + Allopurinol	Allopurinol
STARTED	94 ^[1]	93	93
Treated	92 ^[2]	92	91
COMPLETED	90	86	86
NOT COMPLETED	4	7	7
Adverse Event	1	5	2
Withdrawal by Subject	0	0	1
Various other reasons	3	2	4

[1]	Intent-to-treat (ITT)population: randomized patients
[2]	Modified ITT population: ITT patients with at least 1 dose of study drug

Baseline Characteristics

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Reporting Groups

	Description
Rasburicase	Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
Rasburicase + Allopurinol	Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
Allopurinol	Allopurinol (300 mg/day) given alone as a single agent for 5 days
Total	Total of all reporting groups

Baseline Measures

	Rasburicase	Rasburicase + Allopurinol	Allopurinol	Total
Number of Participants [units: participants]	94	93	93	280
Age, Customized [units: participants]
<65 years	63	65	69	197
>=65 years	31	28	24	83
Gender [units: participants]
Female	35	42	29	106
Male	59	51	64	174

Outcome Measures

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1. Primary:

Plasma Uric Acid Responder [ Time Frame: Day 3 through Day 7 ]

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2. Secondary:

Plasma Uric Acid [ Time Frame: Day 1 to Day 7 ]

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3. Secondary:

Time to Uric Acid Control [ Time Frame: Day 1 to Day 7 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: International Clinical Development, Clinical Study Director
Organization: Sanofi-aventis
e-mail: GV-Contact-us@sanofi-aventis.com

No publications provided

Responsible Party:	International Clinical Development, Clinical Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00230178 History of Changes
Other Study ID Numbers:	EFC4978
Study First Received:	September 28, 2005
Results First Received:	July 22, 2009
Last Updated:	January 8, 2010
Health Authority:	United States: Food and Drug Administration

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