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Pharmacokinetics of Generic to Brand Tacrolimus in Stable Renal Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Sandoz
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01256294
First received: November 1, 2010
Last updated: May 21, 2012
Last verified: May 2012
History of Changes
Results First Received: May 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Transplant
Interventions: Drug: Generic Tacrolimus
Drug: Branded Tacrolimus

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sequence 1 - Branded Tacrolimus / Generic Tacrolimus In Period 1 (Days 1 - 14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis).
Sequence 2 - Generic Tacrolimus / Branded Tacrolimus In Period 1 (Days 1-14) participants received generic tacrolimus (Sandoz) orally twice a day and in Period 2 (Days 15-28) participants received branded tacrolimus (Prograf) orally twice a day. Participants received the same stable dosage of tacrolimus dose they had been taking prior to enrollment (on a milligram for milligram basis).

Participant Flow:   Overall Study
    Sequence 1 - Branded Tacrolimus / Generic Tacrolimus     Sequence 2 - Generic Tacrolimus / Branded Tacrolimus  
STARTED     36     35  
COMPLETED     32     33  
NOT COMPLETED     4     2  
Adverse Event                 1                 0  
Withdrawal by Subject                 1                 1  
Protocol deviation                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
All Participants

Period 1 (Days 1 through 14): Participants randomized to Sequence 1 took branded tacrolimus (Prograf) and participants randomized to Sequence 2 took generic tacrolimus (Sandoz).

Period 2 (Days 15 through 28): Participants randomized to Sequence 1 crossed over to treatment with generic tacrolimus and participants randomized to Sequence 2 crossed over to treatment with branded tacrolimus.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
 		  71  
Age  
[units: years]
Mean ± Standard Deviation 		  52.1  ± 12.5  
Gender  
[units: participants]
 		 
Female     28  
Male     43  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dose-Normalized Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12h) at Steady State   [ Time Frame: Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing. ]
  Show Outcome Measure 1

2.  Primary:   Dose-normalized Maximum Plasma Drug Concentration (Cmax) at Steady State   [ Time Frame: Days 14 and 28: Predose and at 0.5, 1, 1.5, 1.75, 2, 3, 4, 8 and 12 hours after dosing. ]
  Show Outcome Measure 2

3.  Secondary:   Intra-patient Variability of Tacrolimus Pharmacokinetic Parameters   [ Time Frame: Days 7 and 14, and Days 21 and 28. ]
  Show Outcome Measure 3

4.  Secondary:   Trough Plasma Drug Concentration (C0) at Steady State   [ Time Frame: Days 14 and 28: predose ]
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5.  Secondary:   Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)   [ Time Frame: 28 Days ]
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Measure Type Secondary
Measure Title Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Measure Description An AE was defined as the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. An SAE was an event which: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; required or prolonged inpatient hospitalization; was medically significant, i.e., an event that jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame 28 Days  
Safety Issue No  

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.
Safety set

Reporting Groups
  Description
Generic Tacrolimus Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
Branded Tacrolimus Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.

Measured Values
    Generic Tacrolimus     Branded Tacrolimus  
Number of Participants Analyzed  
[units: participants]
 		  71     71  
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)  
[units: participants]
 		   
Any adverse event     8     12  
Serious adverse event     0     1  

No statistical analysis provided for Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)



6.  Secondary:   Number of Participants With Reported Biopsy Proven Acute Rejection Episodes   [ Time Frame: 28 Days ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01256294     History of Changes
Other Study ID Numbers: CERL080AUS90
Study First Received: November 1, 2010
Results First Received: May 21, 2012
Last Updated: May 21, 2012
Health Authority: United States: Institutional Review Board