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Trial record 1 of 1 for:    NCT00114777
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Study of Belatacept in Subjects Who Are Undergoing a Renal Transplant (BENEFIT-EXT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00114777
First Posted: June 20, 2005
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Bristol-Myers Squibb
Results First Submitted: January 4, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Renal Transplantation
Interventions: Drug: Cyclosporin A
Drug: Belatacept Less Intensive Regimen (LI)
Drug: Belatacept More Intensive Regimen (MI)

  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
595 participants enrolled, 578 randomized. Reasons for non-randomization included 13 subjects no longer met study criteria; 3 discontinued on sponsor’s discretion; 1 due to other reason. Of those randomized, 543 were treated. Reasons for non-treatment were not specified.

Reporting Groups
  Description
Belatacept More Intensive (MI) Regimen Belatacept 10 mg/kg intravenous solution on Days 1 and 5 during the first week, and then every other week through 3 months (Weeks 2, 4, 8, and 12) and then every 4 weeks through 6 months (Weeks 16, 20 and 24), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months
Belatacept Less Intensive (LI) Regimen Belatacept 10 mg/kg intravenously on Day 1 and Day 5 during the first week, and then every other week for 4 weeks (Weeks 2 and 4), and then every 4 weeks for 2 months (Weeks 8 and 12), followed by a maintenance dose of belatacept, 5 mg/kg intravenously every 4 weeks thereafter for up to 84 months.
Cyclosporin A (CsA) Cyclosporin A 4-10 mg/kg capsules orally in 2 divided doses, adjusted thereafter to maintain serum concentrations of 150-300 ng/mL during the first month. Subsequently, doses were adjusted to maintain a predefined range of trough serum concentrations of 100-250 ng/mL for up to 84 months.

Participant Flow for 2 periods

Period 1:   Randomization to Month 36
    Belatacept More Intensive (MI) Regimen   Belatacept Less Intensive (LI) Regimen   Cyclosporin A (CsA)
STARTED   184   175   184 
COMPLETED   109   114   100 
NOT COMPLETED   75   61   84 
Death                10                4                3 
No Longer Met Study Criteria                0                0                2 
Lack of Efficacy                19                15                17 
Poor or Non-Compliance                0                0                1 
Adverse Event                34                35                44 
Withdrawal by Subject                3                4                5 
Not Specified                9                3                12 

Period 2:   Long-Term Extension to Month 84
    Belatacept More Intensive (MI) Regimen   Belatacept Less Intensive (LI) Regimen   Cyclosporin A (CsA)
STARTED   104   113   87 
COMPLETED   74   84   57 
NOT COMPLETED   30   29   30 
Death                8                13                7 
No Longer Met Study Criteria                1                0                1 
Lack of Efficacy                1                0                1 
Poor or Non-Compliance                1                1                3 
Adverse Event                15                14                7 
Withdrawal by Subject                2                1                6 
Lost to Follow-up                0                0                2 
Administrative Reason by Sponsor                0                0                1 
Not Specified                2                0                2 



  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.
No text entered.

Reporting Groups
  Description
Belatacept More Intensive (MI) Regimen Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 6, 8, 10, 12, 16, 20, and 24 and 5mg/kg intravenous solution for over 30 minutes every 4 weeks up to 84 months.
Belatacept Less Intensive (LI) Regimen Belatacept 10mg/kg intravenous solution for over 30 minutes on Day 1 and 5 of Week 2, 4, 8, 12 followed by belatacept 5mg/kg intravenous solution every 4 weeks up to 84 months.
Cyclosporin A (CsA) Cyclosporine A 410 mg/kg was capsules, orally, twice daily in 2 divided dose for 1 month, to maintain serum concentration of 150-300 ng/mL. The subsequent dose was adjusted to maintain a predefined range of trough serum concentrations of 100-250/mL, daily for up to 84 months.
Total Total of all reporting groups

Baseline Measures
   Belatacept More Intensive (MI) Regimen   Belatacept Less Intensive (LI) Regimen   Cyclosporin A (CsA)   Total 
Overall Participants Analyzed 
[Units: Participants]
 184   175   184   543 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.7  (12.6)   56.1  (12.4)   55.7  (12.2)   56.2  (12.4) 
Age, Customized 
[Units: Participants]
       
18 to 45 years   32   35   34   101 
46 to 65 years   100   97   108   305 
more than 65 years   52   43   42   137 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      65  35.3%      46  26.3%      68  37.0%      179  33.0% 
Male      119  64.7%      129  73.7%      116  63.0%      364  67.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Survived With a Graft at 12 Months Post-Transplant   [ Time Frame: Month 12 post-transplant ]

2.  Primary:   Percentage of Participants With a Measured Glomerular Filtration Rate (GFR) <60 mL/Min Per 1.73 m^2 at Month 12 or a Decrease in Measured GFR >=10 mL/Min Per 1.73 m^2 From Month 3 to Month 12   [ Time Frame: From Month 3 to Month 12 ]

3.  Secondary:   Measured Glomerular Filtration Rate (GFR) by Month 12 and 24   [ Time Frame: At Month 12 and Month 24 ]

4.  Secondary:   Percentage of Participants With Chronic Allograft Nephropathy (CAN) at Month 12   [ Time Frame: At Month 12 ]

5.  Secondary:   Percentage of Participants Who Survived With a Graft at 24 and 36 Months Post-Transplant   [ Time Frame: Month 24 and Month 36 post-transplant ]

6.  Secondary:   Calculated Glomerular Filtration Rate (GFR) at 6, 12, 24, 36 and 84 Months   [ Time Frame: Months 6, 12, 24, 36 and 84 ]

7.  Secondary:   Change in Calculated GFR at Months 12, 24, 36 and 84   [ Time Frame: Baseline and Months 12, 24, 36 and 84 ]

8.  Secondary:   Number of Participants With Anti-Hypertensive Medications Used to Control Hypertension at 12, 24 and 36 Months   [ Time Frame: Baseline and Months 12, 24 and 36 ]

9.  Secondary:   Percentage of Subjects Who Used Anti-Hypertensive Medications to Control Hypertension at Months 12, 24 and 36   [ Time Frame: Months 12, 24 and 36 ]

10.  Secondary:   Percentage of Participants With New Onset Diabetes Mellitus (NODM) at 12, 24 and 36 Months.   [ Time Frame: Months 12, 24 and 36 ]

11.  Secondary:   Systolic and Diastolic Blood Pressure (BP) at 12, 24 and 36 Months   [ Time Frame: Months 12, 24 and 36 ]

12.  Secondary:   Mean Framingham Risk Score From Baseline to Months 12, 24 and 36   [ Time Frame: Baseline and Months 12, 24 and 36 ]

13.  Secondary:   Percentage of Participants Using Lipid-Lowering Therapy at 12, 24, and 36 Months   [ Time Frame: Months 12, 24 and 36 ]

14.  Secondary:   Change in Total Cholesterol (TC), Non-HDL, LDL and HDL Cholesterol and Triglycerides at 12, 24 and 36   [ Time Frame: Months 12, 24 and 36 ]

15.  Secondary:   Percentage of Participants Who Have an Acute Rejection by Months 6, 12, 24, 36 and 84   [ Time Frame: Months 6, 12, 24, 36 and 84 ]

16.  Secondary:   Number of Participants Using Lymphocyte Depleting Therapy and Steroid-Resistant for Acute Rejection by Months 6, 12, 24, and 36.   [ Time Frame: Months 6, 12, 24 and 36 ]

17.  Secondary:   Number of Participants Based on Severity of Acute Rejection Based on Banff Grade Level by Months 6, 12, 24, 36 and 84   [ Time Frame: Months 6, 12, 24, 36 and 84 ]

18.  Secondary:   Mean Changes in Mental Component and Physical Component Health-Related Quality of Life (SF-36) From Baseline to Months 12, 24 and 36   [ Time Frame: Baseline and Months 12, 24 and 36 ]

19.  Secondary:   Number of Participants With Clinically Significant Changes in Vital Signs up to 36 Months   [ Time Frame: Day 1 to Month 36 ]

20.  Secondary:   Number of Participants With Laboratory Test Abnormalities up to 36 Months   [ Time Frame: Day 1 to Month 36 ]

21.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 36   [ Time Frame: Day 1 to Month 36 ]

22.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Related AEs and SAEs, AEs Leading to Discontinuation and Who Died up to Month 84   [ Time Frame: Day 1 to Month 84 ]

23.  Secondary:   Percentage of Participants With Graft Loss or Death to Month 84   [ Time Frame: Randomization to date of death, up to 84 months ]


  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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00114777     History of Changes
Other Study ID Numbers: IM103-027
First Submitted: June 17, 2005
First Posted: June 20, 2005
Results First Submitted: January 4, 2017
Results First Posted: July 7, 2017
Last Update Posted: October 12, 2017