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Everolimus in de Novo Kidney Transplant Recipients (NEVERWOUND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01410448
First received: August 2, 2011
Last updated: April 3, 2017
Last verified: March 2017
Results First Received: November 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Kidney Transplantation
Interventions: Drug: Everolimus
Drug: Mycophenolate sodium
Drug: Cyclosporine
Drug: Steroids

  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
This study included a 3 month treatment period followed by an observational follow-up period. Participants were treated as per local practice during follow-up and a follow-up evaluation was performed at 12 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized in a 1:1 ratio to one of the 2 treatment groups.

Reporting Groups
  Description
Immediate Everolimus (IE) Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
Delayed Everolimus (DE) The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.

Participant Flow:   Overall Study
    Immediate Everolimus (IE)   Delayed Everolimus (DE)
STARTED   193   190 
Intent-to Treat (ITT) Analysis Set   193   190 
Modified ITT Analysis Set   161   149 
COMPLETED   181   155 
NOT COMPLETED   12   35 
No conversion to everolimus                0                24 
Graft loss                4                1 
Administrative issues                2                1 
Lost to Follow-up                1                0 
Withdrawal by Subject                3                2 
Protocol Violation                0                4 
Death                2                3 



  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
Immediate Everolimus (IE) Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
Delayed Everolimus (DE) The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
Total Total of all reporting groups

Baseline Measures
   Immediate Everolimus (IE)   Delayed Everolimus (DE)   Total 
Overall Participants Analyzed 
[Units: Participants]
 193   190   383 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.46  (11.37)   51.19  (12.29)   51.32  (11.82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      59  30.6%      58  30.5%      117  30.5% 
Male      134  69.4%      132  69.5%      266  69.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Without Wound Healing Complications - Worst-case Scenario   [ Time Frame: 3 months ]

2.  Secondary:   Percentage of Participants Without Wound Healing Complications - Worst-case Scenario   [ Time Frame: 12 months ]

3.  Secondary:   Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario   [ Time Frame: 3 months ]

4.  Secondary:   Patient Survival Rate: Percentage of Deaths - Worst-case Scenario   [ Time Frame: 3 Months, 12 months ]

5.  Secondary:   Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario   [ Time Frame: 3 months ]

6.  Secondary:   Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario   [ Time Frame: 3 months, 12 months ]

7.  Secondary:   Percentage of Participants With BPAR - Worst-case Scenario   [ Time Frame: 3 Months, 12 months ]

8.  Secondary:   Percentage of Participants With Delayed Graft Function (DGF) -   [ Time Frame: 3 Months ]

9.  Secondary:   Duration of DGF   [ Time Frame: 3 months ]

10.  Secondary:   Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT   [ Time Frame: baseline, 3 Months ]

11.  Secondary:   Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT   [ Time Frame: baseline, 12 months ]

12.  Secondary:   Change From Baseline in Serum Creatinine - ITT   [ Time Frame: baseline, 3 months ]

13.  Secondary:   Change From Baseline in Serum Creatinine - Modified ITT   [ Time Frame: baseline, 12 months ]

14.  Secondary:   Percentage of Participants With Proteinuria   [ Time Frame: 3 months ]

15.  Secondary:   Percentage of Participants With Acute Rejection (AR)   [ Time Frame: 12 months ]

16.  Secondary:   Percentage of Participants With a New Onset of Malignancy   [ Time Frame: 12 months ]

17.  Secondary:   Percentage of Participants With a New Onset of Diabetes   [ Time Frame: 12 months ]


  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: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01410448     History of Changes
Other Study ID Numbers: CRAD001AIT25
2011-002866-19 ( EudraCT Number )
Study First Received: August 2, 2011
Results First Received: November 21, 2016
Last Updated: April 3, 2017