Pharmacokinetics of LCP-Tacro in Stable Liver Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
CTI Clinical Trial and Consulting Services
Information provided by (Responsible Party):
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00608244
First received: January 23, 2008
Last updated: August 14, 2015
Last verified: August 2015
Results First Received: June 10, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver 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

All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.

On Day 22, patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.

LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.


Participant Flow:   Overall Study
    LCP-Tacro  
STARTED     59  
COMPLETED     57  
NOT COMPLETED     2  
Adverse Event                 1  
Low trough levels                 1  



  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.
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Reporting Groups
  Description
LCP-Tacro Evaluation of steady state tacrolimus exposure (AUC0-24) and trough levels (C24) in stable liver transplant recipients converted from Prograf to LCP-Tacro in a 3-sequence study design and validate the dose conversion ratio determined in the Phase 1 program.

Baseline Measures
    LCP-Tacro  
Number of Participants  
[units: participants]
  59  
Age  
[units: years]
Mean (Standard Deviation)
  49.8  (11.15)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     59  
>=65 years     0  
Gender  
[units: participants]
 
Female     26  
Male     33  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     2  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     8  
White     46  
More than one race     1  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     59  



  Outcome Measures
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1.  Primary:   Evaluation of Steady State Tacrolimus Trough Levels (C24).   [ Time Frame: 7 Days ]

2.  Primary:   Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).   [ Time Frame: 7 Days ]

3.  Primary:   Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).   [ Time Frame: 21 Days ]

4.  Primary:   Evaluation of Steady State Tacrolimus Exposure (AUC 0-24) on Day 21.   [ Time Frame: 21 Days ]

5.  Primary:   Safety Evaluation   [ Time Frame: 52 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 A/S
phone: +45 20553877
e-mail: csy@veloxis.com


No publications provided by Veloxis Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00608244     History of Changes
Other Study ID Numbers: LCP Tacro 2012
Study First Received: January 23, 2008
Results First Received: June 10, 2014
Last Updated: August 14, 2015
Health Authority: United States: Food and Drug Administration