Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

This study has been completed.

Study NCT00038948 Information provided by Wyeth is now a wholly owned subsidiary of Pfizer

First Received on June 5, 2002. Last Updated on April 22, 2010 History of Changes

Results First Received: May 29, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Renal Transplantation
Interventions:	Drug: Sirolimus Drug: tacrolimus Drug: Cyclosporine A

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
Patients were recruited worldwide from January 2002 to September 2003.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened for two weeks.

Reporting Groups

	Description
SRL Conversion in Stable Renal Transplant Recipients	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
CNI Continuation in Stable Renal Transplant Recipients	Continued calcineurin inhibitor immunosuppression therapy

Participant Flow: Overall Study

	SRL Conversion in Stable Renal Transplant Recipients	CNI Continuation in Stable Renal Transplant Recipients
STARTED	555	275
COMPLETED	386	198
NOT COMPLETED	169	77
Adverse Event	131	43
Lost to Follow-up	4	4
Nonmedical event	5	7
Withdrawal by Subject	23	10
Protocol Violation	3	7
Lack of Efficacy	3	6

Baseline Characteristics

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Reporting Groups

	Description
SRL Conversion in Stable Renal Transplant Recipients	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
CNI Continuation in Stable Renal Transplant Recipients	Continued calcineurin inhibitor immunosuppression therapy

Baseline Measures

	SRL Conversion in Stable Renal Transplant Recipients	CNI Continuation in Stable Renal Transplant Recipients	Total
Number of Participants [units: participants]	555	275	830
Age [units: years] Median ( Full Range )	45.00 ( 13.20 to 75.10 )	43.50 ( 12.80 to 74.00 )	44.50 ( 12.80 to 75.10 )
Gender [units: participants]
Female	170	81	251
Male	385	194	579

Outcome Measures

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1. Primary:

Nankivell Glomerular Filtration Rate (GFR) [ Time Frame: 52 weeks ]

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2. Secondary:

First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. [ Time Frame: 52 and 104 weeks ]

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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 PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

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: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00038948 History of Changes
Other Study ID Numbers:	0468H1-316
Study First Received:	June 5, 2002
Results First Received:	May 29, 2009
Last Updated:	April 22, 2010
Health Authority:	United States: Food and Drug Administration