Pharmacokinetics of LCP-Tacro in Stable Kidney 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:
NCT00496483
First received: July 2, 2007
Last updated: June 25, 2015
Last verified: June 2015
Results First Received: May 29, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Failure
Interventions: Drug: LCP Tacro (tacrolimus)
Drug: Prograf

  Participant Flow
  Hide Participant Flow

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 7 to 12 ng/mL.


Participant Flow:   Overall Study
    LCP-Tacro  
STARTED     60  
Dosed     51  
COMPLETED     48  
NOT COMPLETED     12  
Not dosed                 9  
Adverse Event                 2  
Lack of Efficacy                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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
LCP-Tacro LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.

Baseline Measures
    LCP-Tacro  
Number of Participants  
[units: participants]
  60  
Age  
[units: years]
Mean (Standard Deviation)
  45.6  (12.08)  
Gender  
[units: participants]
 
Female     19  
Male     41  
Region of Enrollment  
[units: participants]
 
United States     60  



  Outcome Measures
  Show All Outcome Measures

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).   [ Time Frame: 21 days ]

5.  Secondary:   Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.   [ Time Frame: 21 days ]

6.  Secondary:   Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.   [ Time Frame: 21 days ]

7.  Secondary:   Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.   [ Time Frame: 21 days ]

8.  Secondary:   Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.   [ Time Frame: 7 days ]

9.  Secondary:   Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.   [ Time Frame: 7 days ]

10.  Secondary:   Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.   [ Time Frame: 7 days ]

11.  Secondary:   Safety Evaluation   [ Time Frame: 52 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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, Sr VP, Global Clinical Development and Operations
Organization: Veloxis A/S
phone: +45 20553877
e-mail: csy@veloxis.com



Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00496483     History of Changes
Other Study ID Numbers: LCP-Tacro 2011
Study First Received: July 2, 2007
Results First Received: May 29, 2014
Last Updated: June 25, 2015
Health Authority: United States: Food and Drug Administration