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Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx (LCPTacro3002)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01187953
First received: August 23, 2010
Last updated: April 18, 2016
Last verified: April 2016
Results First Received: April 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Renal Failure
Interventions: Drug: Prograf (tacrolimus)
Drug: LCP-Tacro

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
LCP-Tacro

The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

Prograf (Tacrolimus)

Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.

Prograf (tacrolimus): Administered per current product labeling


Participant Flow:   Overall Study
    LCP-Tacro   Prograf (Tacrolimus)
STARTED   268   275 
Dosed   266   271 
COMPLETED   253   254 
NOT COMPLETED   15   21 
Death                11                13 
Adverse Event                1                2 
Lost to Follow-up                0                3 
Withdrawal by Subject                3                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.
The patient sample was predominantly White (76.8%) and male (65.4%).

Reporting Groups
  Description
LCP-Tacro

The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.

Prograf (Tacrolimus)

Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.

Prograf (tacrolimus): Administered per current product labeling

Total Total of all reporting groups

Baseline Measures
   LCP-Tacro   Prograf (Tacrolimus)   Total 
Overall Participants Analyzed 
[Units: Participants]
 268   275   543 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   252   247   499 
>=65 years   16   28   44 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.8  (13.29)   46.9  (14.26)   45.8  (13.82) 
Gender 
[Units: Participants]
     
Female   94   94   188 
Male   174   181   355 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   74   79   153 
Not Hispanic or Latino   194   196   390 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   10   10   20 
Native Hawaiian or Other Pacific Islander   1   1   2 
Black or African American   10   15   25 
White   203   214   417 
More than one race   0   0   0 
Unknown or Not Reported   44   34   78 
Region of Enrollment 
[Units: Participants]
     
Argentina   1   1   2 
Singapore   1   1   2 
United States   67   70   137 
Spain   24   21   45 
New Zealand   2   3   5 
Poland   27   26   53 
Brazil   29   29   58 
Mexico   27   29   56 
Italy   6   6   12 
Australia   11   11   22 
France   35   38   73 
Serbia   6   5   11 
Germany   32   35   67 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 25.72  (4.648)   26.68  (4.948)   26.21  (4.822) 
Diabetes at the time of transplant 
[Units: Participants]
     
Patients with diabetes at transplant   50   56   106 
Patients without diabetes at transplant   218   219   437 
Time from transplant to first dose 
[Units: Hours]
Mean (Standard Deviation)
 34.15  (8.878)   34.38  (9.735)   34.27  (9.312) 
Donor Type 
[Units: Participants]
     
Living   135   129   264 
Deceased   133   145   278 
Missing   0   1   1 


  Outcome Measures
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1.  Primary:   The Primary Efficacy Endpoint for the Study is the Proportion of Treatment Failures Within 12 Months After Randomization to Study Drug.   [ Time Frame: 360 days ]

2.  Secondary:   For the 24-month Analysis, the Endpoint Includes Additional Treatment Failures That Occurred During the 12-month Treatment Extension Period, up to Day 734 After the Randomization Date.   [ Time Frame: 734 days ]


  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
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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:
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: Christina Sylvest
Organization: Veloxis Pharmaceuticals
phone: +4520553877
e-mail: csy@veloxis.com



Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01187953     History of Changes
Other Study ID Numbers: LCP-Tacro-3002
Study First Received: August 23, 2010
Results First Received: April 23, 2015
Last Updated: April 18, 2016
Health Authority: United States: Food and Drug Administration