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Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients

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.
ClinicalTrials.gov Identifier: NCT00496483
Recruitment Status : Completed
First Posted : July 4, 2007
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Renal Failure
Interventions: Drug: LCP Tacro (tacrolimus)
Drug: Prograf

  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

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 
Overall Participants Analyzed 
[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

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

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

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
First Submitted: July 2, 2007
First Posted: July 4, 2007
Results First Submitted: May 29, 2014
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015