Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program (Senator)

This study has been terminated.
(The study was terminated because the required sample size of 240-260 de novo senior renal transplant patients was not achieved within a reasonable time.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00956293
First received: August 7, 2009
Last updated: May 23, 2014
Last verified: May 2014
Results First Received: March 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Transplantation
Interventions: Drug: Basiliximab
Drug: Enteric Coated Mycophenolic Acid (MPA)
Drug: RAD001
Drug: Cyclosporin A (CsA)
Drug: Corticosteroids

  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
The study consisted of a main period and a 54 month observation follow-up period. The main period included a pre-randomized treatment phase (6 weeks) and a randomized treatment phase (18 weeks). All randomized participants, who participated in the main period, were eligible for the follow-up period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At baseline (BL) 1 (pre-randomization), eligible participants received a CNI-based regimen for 6 weeks. At BL2 (randomization), eligible participants were randomized in a 1:2 ratio to the control group or everolimus group.

Reporting Groups
  Description
Control Group During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
Everolimus Group During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
Pre-randomized Group Participants, who met BL1 eligibility, were enrolled into the study.

Participant Flow for 3 periods

Period 1:   Main Period (Pre-randomization)
    Control Group     Everolimus Group     Pre-randomized Group  
STARTED     0     0     207  
Enrolled Safety Set     0     0     203  
COMPLETED     0     0     77  
NOT COMPLETED     0     0     130  
Not specified (data missing)                 0                 0                 1  
Death                 0                 0                 1  
Protocol Violation                 0                 0                 1  
Abnormal test procedure result                 0                 0                 2  
Administrative problems                 0                 0                 6  
Graft loss                 0                 0                 7  
Withdrawal by Subject                 0                 0                 12  
Lack of Efficacy                 0                 0                 20  
Adverse Event                 0                 0                 36  
Abnormal laboratory value                 0                 0                 44  

Period 2:   Main Period (Randomization)
    Control Group     Everolimus Group     Pre-randomized Group  
STARTED     24     53     0  
Full Analysis Set     24     51 [1]   0  
Randomized Safety Set     24     51     0  
COMPLETED     23     26     0  
NOT COMPLETED     1     27     0  
Abnormal laboratory value                 0                 2                 0  
Lack of Efficacy                 1                 10                 0  
Adverse Event                 0                 15                 0  
[1] Two participants, randomized to this arm, did not receive everolimus.

Period 3:   Follow-up Period
    Control Group     Everolimus Group     Pre-randomized Group  
STARTED     20     32     0  
COMPLETED     0     0     0  
NOT COMPLETED     20     32     0  
Follow-up period was terminated.                 20                 32                 0  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Control Group During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
Everolimus Group During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
Total Total of all reporting groups

Baseline Measures
    Control Group     Everolimus Group     Total  
Number of Participants  
[units: participants]
  24     51     75  
Age  
[units: Years]
Mean ± Standard Deviation
  69.3  ± 3.1     68.4  ± 3.3     68.7  ± 3.3  
Gender  
[units: Participants]
     
Female     8     26     34  
Male     16     25     41  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Renal Function by Glomerular Filtration Rate (GFR) Via Cockcroft-Gault Method   [ Time Frame: Month 6 ]

2.  Secondary:   Renal Function by GFR Via Modification of Diet in Renal Diseases (MDRD) and Nankivell Method   [ Time Frame: Month 6 ]

3.  Secondary:   Renal Function by Serum Creatinine   [ Time Frame: Months 6, 12, 24, 36, 48 and 60 ]

4.  Secondary:   Biopsy Proven Acute Rejection (BPAR), Graft Loss and Death   [ Time Frame: Months 6, 12, 24, 36, 48 and 60 ]

5.  Secondary:   Occurrence of Treatment Failures   [ Time Frame: Month 6 ]

6.  Secondary:   Evolution of Renal Function (Creatinine Slope)   [ Time Frame: Week 7, Month 6 ]

7.  Secondary:   CD25 Saturation on Lymphocytes   [ Time Frame: Month 6 ]

8.  Secondary:   Number of Participants Who Experienced Adverse Events, Serious Adverse Events and Death   [ Time Frame: Months 6, 12, 24, 36, 48 and 60 ]

9.  Secondary:   Renal Function by GFR Over Time   [ Time Frame: Months 12, 24, 36, 48 and 60 ]

10.  Secondary:   Renal Function by Proteinuria   [ Time Frame: Months12, 24, 36, 48 and 60 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: +1 (862) 778-1873


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00956293     History of Changes
Other Study ID Numbers: CRAD001ADE19, EudraCT-NO. 2008-005109-20, 2008-005109-20
Study First Received: August 7, 2009
Results First Received: March 26, 2014
Last Updated: May 23, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices