Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00154297

First received: September 8, 2005

Last updated: March 30, 2011

Last verified: March 2011

History of Changes

Results First Received: January 4, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Renal Transplantation
Intervention:	Drug: Everolimus (RAD001)

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
Immediate Everolimus	Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
Delayed Everolimus	Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.

Participant Flow: Overall Study

	Immediate Everolimus	Delayed Everolimus
STARTED	65 ^[1]	74 ^[1]
COMPLETED	57 ^[2]	67 ^[2]
NOT COMPLETED	8	7
Death	5	2
Withdrawal by Subject	0	5
Lost to Follow-up	3	0

[1]	Randomized population.
[2]	Completed study by 12 month.

Baseline Characteristics

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Reporting Groups

	Description
Immediate Everolimus	Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
Delayed Everolimus	Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
Total	Total of all reporting groups

Baseline Measures

	Immediate Everolimus	Delayed Everolimus	Total
Number of Participants [units: participants]	65	74	139
Age ^[1] [units: years] Mean ± Standard Deviation	57.3 ± 10.46	58.4 ± 9.86	57.9 ± 10.13
Gender ^[1] [units: participants]
Female	19	20	39
Male	46	54	100

[1]	baseline measure based on randomized population.

Outcome Measures

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1. Primary:

Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months [ Time Frame: Month 3 ]

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2. Secondary:

Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation. [ Time Frame: at 6 Month post-transplantation ]

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3. Secondary:

Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation. [ Time Frame: at 12 Month post-transplantation ]

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4. Secondary:

Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period [ Time Frame: Month 12 ]

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Measure Type	Secondary
Measure Title	Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period
Measure Description	The number of patients who underwent any dialysis within the 12-month treatment period.
Time Frame	Month 12
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intention to treat (ITT) population.

Reporting Groups

	Description
Immediate Everolimus	Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
Delayed Everolimus	Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.

Measured Values

	Immediate Everolimus	Delayed Everolimus
Number of Participants Analyzed [units: participants]	65	74
Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period [units: Participants]	16	24

No statistical analysis provided for Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period

5. Secondary:

Duration of Dialysis [ Time Frame: 12 months ]

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6. Secondary:

Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period [ Time Frame: Month 12 ]

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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 Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00154297 History of Changes
Other Study ID Numbers:	CRAD001A2420
Study First Received:	September 8, 2005
Results First Received:	January 4, 2011
Last Updated:	March 30, 2011
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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