IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

This study has been completed.

Study NCT00294515 Information provided by Hoffmann-La Roche

First Received on February 21, 2006. Last Updated on July 30, 2010 History of Changes

Results First Received: June 2, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Cytomegalovirus Infections
Intervention:	Drug: Valganciclovir

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
Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days

Participant Flow: Overall Study

	Valganciclovir up to 100 Days	Valganciclovir up to 200 Days
STARTED	166 ^[1]	160 ^[1]
COMPLETED	132	132
NOT COMPLETED	34	28

[1]	Randomized

Baseline Characteristics

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Reporting Groups

	Description
Valganciclovir up to 100 Days	900 mg valganciclovir orally daily for up to 100 days
Valganciclovir up to 200 Days	900 mg valganciclovir orally daily for up to 200 days

Baseline Measures

	Valganciclovir up to 100 Days	Valganciclovir up to 200 Days	Total
Number of Participants [units: participants]	164	156	320
Age ^[1] [units: years] Mean ± Standard Deviation	48.5 ± 13.76	47.0 ± 13.51	47.8 ± 13.64
Gender ^[1] [units: participants]
Female	45	40	85
Male	119	116	235

[1]	Safety population

Outcome Measures

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1. Primary:

Percentage of Patients Who Developed Cytomegalovirus (CMV) Disease up to Month 12 Post-transplant [ Time Frame: 12 months post-transplant ]

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2. Secondary:

Percentage of Patients Who Developed CMV Disease up to Month 6 Post-transplant [ Time Frame: 6 months post-transplant ]

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3. Secondary:

Percentage of Patients Who Developed CMV Disease up to Month 9 Post-transplant [ Time Frame: 9 months post-transplant ]

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4. Secondary:

Percentage of Patients Who Developed CMV Disease up to Month 18 Post-transplant [ Time Frame: 18 months post-transplant ]

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5. Secondary:

Percentage of Patients Who Developed CMV Disease up to Month 24 Post-transplant [ Time Frame: 24 months post-transplant ]

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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: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property 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: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Humar A, Lebranchu Y, Vincenti F, Blumberg EA, Punch JD, Limaye AP, Abramowicz D, Jardine AG, Voulgari AT, Ives J, Hauser IA, Peeters P. The efficacy and safety of 200 days valganciclovir cytomegalovirus prophylaxis in high-risk kidney transplant recipients. Am J Transplant. 2010 May;10(5):1228-37. Epub 2010 Mar 26.

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00294515 History of Changes
Other Study ID Numbers:	NT18435
Study First Received:	February 21, 2006
Results First Received:	June 2, 2010
Last Updated:	July 30, 2010
Health Authority:	United States: Food and Drug Administration