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Trial record 1 of 1 for:    NCT00817206
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Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00817206
First Posted: January 6, 2009
Last Update Posted: September 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PPD
Information provided by (Responsible Party):
Veloxis Pharmaceuticals
Results First Submitted: August 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Renal Failure
Interventions: Drug: LCP-Tacro
Drug: Prograf

  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

LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)

LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.

Prograf (Tacrolimus)

Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)

Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.


Participant Flow:   Overall Study
    LCP-Tacro   Prograf (Tacrolimus)
STARTED   163   163 
COMPLETED   142   154 
NOT COMPLETED   21   9 
Adverse Event                10                3 
Protocol Violation                0                2 
Lost to Follow-up                0                1 
Death                2                0 
Withdrawal by Subject                7                3 
Physician Decision                2                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.
Demographic information is given for all randomized subjects.

Reporting Groups
  Description
LCP-Tacro

LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)

LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.

Prograf (Tacrolimus)

Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)

Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.

Total Total of all reporting groups

Baseline Measures
   LCP-Tacro   Prograf (Tacrolimus)   Total 
Overall Participants Analyzed 
[Units: Participants]
 163   163   326 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   146   137   283 
>=65 years   17   26   43 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.4  (11.71)   50.2  (13.49)   50.3  (1.61) 
Gender 
[Units: Participants]
     
Female   46   61   107 
Male   117   102   219 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   26   29   55 
Not Hispanic or Latino   137   134   271 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   3   3   6 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   36   34   70 
White   120   117   237 
More than one race   0   0   0 
Unknown or Not Reported   4   7   11 
Region of Enrollment 
[Units: Participants]
     
United States   122   121   243 
Europe   41   42   83 


  Outcome Measures

1.  Primary:   Composite Endpoint for Efficacy Failure Within 12 Months of Randomization: Death, Graft Failure, Biopsy-proven Acute Rejection or Loss to Follow-up.   [ 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
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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 A/S
phone: +45 20553877
e-mail: csy@veloxis.com



Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00817206     History of Changes
Other Study ID Numbers: LCP-Tacro 3001
First Submitted: December 19, 2008
First Posted: January 6, 2009
Results First Submitted: August 11, 2015
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015