Belatacept Pharmacokinetic Trial in Renal Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00578448
First received: December 19, 2007
Last updated: December 16, 2013
Last verified: December 2013
Results First Received: October 28, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Transplantation
Intervention: Drug: Belatacept

  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
First participant, first visit: 3 March 2008. Last subject, last visit 6 September 2012. Participants had received a renal transplant from a living or deceased donor with an anticipated cold ischemia time of less than (<) 24 hours (h)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
14 participants enrolled; 12 received study drug; 2 not treated due to: kidney damage (1) and prolonged cold ischemia (1). Study continued for up to 3 years until drug approval in participant's country. Participants continued in a 1 year extension after conclusion of the 3rd year.

Reporting Groups
  Description
Belatacept 10mg/kg; 5mg/kg Maintenance Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial (3 years and then a 1 year extension was available for those who completed the 3rd year).

Participant Flow for 2 periods

Period 1:   Day 1 up to 3 Years of Planned Study
    Belatacept 10mg/kg; 5mg/kg Maintenance  
STARTED     12  
COMPLETED     9  
NOT COMPLETED     3  
Death                 1  
Adverse Event                 1  
started marketed Cellcept and Prograf                 1  

Period 2:   1 Year Long Term Extension (LTE)
    Belatacept 10mg/kg; 5mg/kg Maintenance  
STARTED     9  
COMPLETED     8  
NOT COMPLETED     1  
Adverse Event                 1  



  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.
Participants treated with study drug after renal transplant.

Reporting Groups
  Description
IV Belatacept 10mg/kg With 5mg/kg Maintenance Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial.

Baseline Measures
    IV Belatacept 10mg/kg With 5mg/kg Maintenance  
Number of Participants  
[units: participants]
  12  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  48.7  ± 19.05  
Gender  
[units: participants]
 
Female     4  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     4  
Mexico     6  
Argentina     2  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  74.90  ± 17.735  



  Outcome Measures
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1.  Primary:   Mean Belatacept Serum Concentrations Between Weeks 12 and 16 by Nominal Collection Time, Following 10mg/kg IV Belatacept - Pharmacokinetic Population   [ Time Frame: Day 84 to Day 112 ]

2.  Primary:   Maximum Observed Serum Concentration (Cmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept and Trough Serum Concentration Prior to Dosing (Cmin) - Pharmacokinetic Population   [ Time Frame: Day 84 to Day 112 ]

3.  Primary:   Time of Maximum Observed Serum Concentration (Tmax) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population   [ Time Frame: Day 84 to Day 112 ]

4.  Primary:   Area Under the Concentration Time Curve Within a Dosing Interval (AUC) (TAU) Between Weeks 12 and 16 Following 10 mg/kg IV Belatacept - Pharmacokinetic Population   [ Time Frame: Day 82 to Day 112 ]

5.  Primary:   Total Body Clearance (CLT) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population   [ Time Frame: Day 84 to Day 112 ]

6.  Primary:   Steady-state Volume Distribution (Vss) Following 10mg/kg IV Belatacept Between Weeks 12 and 16 - Pharmacokinetic Population   [ Time Frame: Day 84 to Day 112 ]

7.  Primary:   Serum Half Life (T-HALF) Between Weeks 12 and 16 Following 10mg/kg IV Belatacept - Pharmacokinetic Population   [ Time Frame: Day 84 to Day 112 ]

8.  Secondary:   Summary of Trough Serum Concentration of Belatacept Prior to Dosing up to 3 Years Post Transplantation - Pharmacokinetic Population   [ Time Frame: Day 1 to Day 1092 ]

9.  Secondary:   Acute Rejection, Graft Loss, and Death up to 3 Years Post Transplantation in Planned Study and 1 Year Long Term Extension - All Treated Participants   [ Time Frame: Day 1 up to 4 years post transplantation ]

10.  Secondary:   Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Tryptophan - All Treated Participants   [ Time Frame: Baseline to Day 364 ]

11.  Secondary:   Mean Change From Baseline to Days 5, 28, 112, 168, and 364 in Kynurenine - All Treated Participants   [ Time Frame: Day 1 to Day 364 ]


  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: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00578448     History of Changes
Other Study ID Numbers: IM103-047
Study First Received: December 19, 2007
Results First Received: October 28, 2013
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration
Mexico: Subsecretaria de Regulacion y Fomento Sanitario
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica