Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00658320

First received: April 10, 2008

Last updated: August 10, 2011

Last verified: August 2011

History of Changes

Results First Received: August 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Kidney Transplantation
Interventions:	Drug: Everolimus Drug: Mycophenolate mofetil (MMF) Drug: Basiliximab Drug: Cyclosporine A Drug: Corticosteroid

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
Randomization was conducted within 24 hours post reperfusion.

Reporting Groups

Description

Everolimus + Reduced Dose of Cyclosporine

An initial everolimus dose of 0.75mg orally twice daily (1.5mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.

Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine

Patients were treated with 1 gram twice a day (2grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.

Participant Flow: Overall Study

	Everolimus + Reduced Dose of Cyclosporine	Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine
STARTED	61	61
COMPLETED	56	58
NOT COMPLETED	5	3
Subject withdrew consent	5	3

Baseline Characteristics

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Reporting Groups

	Description
Everolimus + Reduced Dose of Cyclosporine	An initial everolimus dose of 0.75mg orally twice daily (1.5mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8ng/mL).Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine	Patients were treated with 1 gram twice a day (2grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice.
Total	Total of all reporting groups

Baseline Measures

	Everolimus + Reduced Dose of Cyclosporine	Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine	Total
Number of Participants [units: participants]	61	61	122
Age [units: years] Mean ± Standard Deviation	42.5 ± 14.13	38.6 ± 11.36	40.5 ± 12.92
Gender [units: participants]
Female	15	24	39
Male	46	37	83

Outcome Measures

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1. Primary:

Number of Patients With Composite Efficacy Endpoint [ Time Frame: 12 months ]

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2. Secondary:

Number Participants With Combined Graft Loss, Death or Loss to Follow-up [ Time Frame: 12 months ]

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3. Secondary:

Renal Function Measured by Calculated Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula [ Time Frame: at 12 month ]

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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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

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: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharma K.K.
ClinicalTrials.gov Identifier:	NCT00658320 History of Changes
Obsolete Identifiers:	NCT00856466
Other Study ID Numbers:	CRAD001A1202
Study First Received:	April 10, 2008
Results First Received:	August 10, 2011
Last Updated:	August 10, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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