Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant

This study has been completed.

Study NCT00118742 Information provided by Hoffmann-La Roche

First Received on June 30, 2005. Last Updated on July 30, 2010 History of Changes

Results First Received: May 13, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Liver Transplantation
Interventions:	Drug: mycophenolate mofetil [CellCept] Drug: Tacrolimus Drug: Cyclosporine Drug: Sirolimus

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 from 43 study centers in the US and Canada over a period of 3 years (24-Aug-05 to 03-Jul-08)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible for the study were adult patients (18 to 74 years) who had received a single primary orthotopic liver transplant and were receiving or were scheduled to receive treatment with CellCept® + calcineurin inhibitor (CNI)

Reporting Groups

	Description
CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
CellCept + Sirolimus	CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months

Participant Flow: Overall Study

	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept + Sirolimus
STARTED	145	148
COMPLETED	96	82
NOT COMPLETED	49	66

Baseline Characteristics

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Reporting Groups

	Description
CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
CellCept + Sirolimus	CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months

Baseline Measures

	CellCept + CNI (Tacrolimus or Cyclosporine)	CellCept + Sirolimus	Total
Number of Participants [units: participants]	145	148	293
Age [units: years] Mean ± Standard Deviation	53.4 ± 7.88	53.2 ± 8.83	53.3 ± 8.36
Gender [units: participants]
Female	35	38	73
Male	110	110	220
Race/Ethnicity, Customized [units: participants]
American Indian	3	4	7
Asian or Pacific Islander	3	11	14
Black	11	8	19
White	126	125	251
Other	2	0	2
Height [units: cm] Mean ± Standard Deviation	173.6 ± 10.04	173.0 ± 10.26	173.3 ± 10.14
Weight [units: kg] Mean ± Standard Deviation	79 ± 16.32	77.9 ± 17.56	78.4 ± 16.94

Outcome Measures

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1. Primary:

Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant [ Time Frame: 12 months posttransplant ]

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2. Secondary:

Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant [ Time Frame: 6 months posttransplant ]

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3. Secondary:

Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant [ Time Frame: 24 months posttransplant ]

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4. Secondary:

Change From Baseline in Creatinine Clearance [ Time Frame: 6, 12, and 24 months posttransplantation ]

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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
There were no overall limitations and caveats.

Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00118742 History of Changes
Other Study ID Numbers:	ML18423
Study First Received:	June 30, 2005
Results First Received:	May 13, 2009
Last Updated:	July 30, 2010
Health Authority:	United States: Food and Drug Administration