Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01438710
First received: September 20, 2011
Last updated: May 6, 2015
Last verified: April 2015
Results First Received: March 23, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Renal Failure
Tremors
Interventions: Drug: Prograf
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

After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.

LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.

Prograf

All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.

Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.


Participant Flow for 2 periods

Period 1:   First Week of Treatment
    LCP-Tacro     Prograf  
STARTED     0 [1]   44  
COMPLETED     0 [1]   41  
NOT COMPLETED     0     3  
[1] Patients are only treated with Prograf/generic Tacrolimus during the first week.

Period 2:   Second Week of Treatment
    LCP-Tacro     Prograf  
STARTED     41 [1]   0 [2]
COMPLETED     40     0 [2]
NOT COMPLETED     1     0  
[1] Patients completing the first week will continue on LCP-Tacro treatment during the second week.
[2] Patients are only treated with LCP-Tacro during the second week.



  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.
44 patients started on the initial one-week treatment on Prograf and 41 were switched to the one-week LCP-Tacro treatment. 40 patients completed the one-week treatment on LCP-Tacro and continued into the 24-months extended use period.

Reporting Groups
  Description
Prograf

Tacrolimus capsules for twice daily oral administration

Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.


Baseline Measures
    Prograf  
Number of Participants  
[units: participants]
  44  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     41  
>=65 years     3  
Age  
[units: years]
Mean (Standard Deviation)
  47.8  (13.68)  
Gender  
[units: participants]
 
Female     10  
Male     34  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     8  
Not Hispanic or Latino     36  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     6  
White     34  
More than one race     2  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     44  
Target Trough Range (low), ng/mL  
[units: ng/mL]
Mean (Standard Deviation)
  5.72  (1.912)  
Target Trough Range (high), ng/mL  
[units: ng/mL]
Mean (Standard Deviation)
  8.68  (1.863)  
Height, cm  
[units: cm]
Mean (Standard Deviation)
  173.63  (8.424)  
Weight, kg  
[units: kg]
Mean (Standard Deviation)
  88.16  (19.707)  
BMI, kg/m2  
[units: kg/m2]
Mean (Standard Deviation)
  29.20  (5.979)  
Time from current kidney transplant to enrolment, months  
[units: Months]
Mean (Standard Deviation)
  16.85  (14.455)  
Donor type for current kidney transplant, n  
[units: participants]
 
Living donor     15  
Deceased donor     29  



  Outcome Measures

1.  Primary:   Evaluation of Hand Tremor and Stable Kidney Transplant Patients When Switched From Prograf to LCP-Tacro.   [ Time Frame: 14 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


No publications provided


Responsible Party: Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01438710     History of Changes
Other Study ID Numbers: LCP-Tacro 3003
Study First Received: September 20, 2011
Results First Received: March 23, 2015
Last Updated: May 6, 2015
Health Authority: United States: Food and Drug Administration