Trial record 1 of 1 for:    NCT00817206
Previous Study | Return to List | Next Study

Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Veloxis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00817206
First received: December 19, 2008
Last updated: August 11, 2015
Last verified: August 2015
Results First Received: August 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Failure
Interventions: Drug: LCP-Tacro
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

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
  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.
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  
Number of Participants  
[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
  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
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
Study First Received: December 19, 2008
Results First Received: August 11, 2015
Last Updated: August 11, 2015
Health Authority: United States: Food and Drug Administration