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Trial record 1 of 1 for:    NCT00402168
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A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00402168
First received: November 20, 2006
Last updated: November 7, 2016
Last verified: November 2016
Results First Received: November 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Transplant
Interventions: Drug: Belatacept
Drug: Cyclosporine A
Drug: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
173 participants were enrolled, 2 participants discontinued the study following randomization, without receiving any study drug.

Reporting Groups
  Description
Belatacept 5 mg/kg Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
Calcineurin Inhibitor (CNI) Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.

Participant Flow for 4 periods

Period 1:   Randomized
    Belatacept 5 mg/kg   Calcineurin Inhibitor (CNI)
STARTED   84   89 
COMPLETED   83   88 
NOT COMPLETED   1   1 
Lost to Follow-up                1                0 
Withdrawal by Subject                0                1 

Period 2:   Treatment (up to 12 Months)
    Belatacept 5 mg/kg   Calcineurin Inhibitor (CNI)
STARTED   83   88 
COMPLETED   81   86 
NOT COMPLETED   2   2 
Death                0                1 
Lack of Efficacy                2                0 
non-specified                0                1 

Period 3:   Long Term (LT)
    Belatacept 5 mg/kg   Calcineurin Inhibitor (CNI)
STARTED   81   81 [1] 
COMPLETED   70   64 
NOT COMPLETED   11   17 
Adverse Event                1                5 
Withdrawal by Subject                4                7 
Pregnancy                0                1 
Lost to Follow-up                1                0 
Death                4                0 
Lack of Efficacy                0                2 
non-specified                1                2 
[1] 5 completed 12 months, did not enter long term: 1 AE, 1 lack of efficacy, 3 other(non-specified).

Period 4:   Switched From CNI to Belatacept in LT
    Belatacept 5 mg/kg   Calcineurin Inhibitor (CNI)
STARTED   38 [1]   0 [2] 
COMPLETED   32   0 
NOT COMPLETED   6   0 
Withdrawal by Subject                2                0 
Adverse Event                4                0 
[1] Participants switched from CNI to Belatacept during LT period.
[2] Out of 81 starting LT period in CNI group, 38 switched from CNI to Belatacept during the LT period.



  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 randomized to a treatment arm.

Reporting Groups
  Description
Belatacept 5 mg/kg Belatacept 5 mg/kg IV every 28 days.
Calcineurin Inhibitor (CNI) Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
Total Total of all reporting groups

Baseline Measures
   Belatacept 5 mg/kg   Calcineurin Inhibitor (CNI)   Total 
Overall Participants Analyzed 
[Units: Participants]
 84   89   173 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.3  (13.5)   44.3  (13.0)   44.8  (13.2) 
Age, Customized 
[Units: Participants]
     
18 - 45 years   42   47   89 
46 - 65 years   37   36   73 
Greater than (>) 65 years   5   6   11 
Gender 
[Units: Participants]
Count of Participants
     
Female      18  21.4%      29  32.6%      47  27.2% 
Male      66  78.6%      60  67.4%      126  72.8% 


  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)   [ Time Frame: Baseline to 12 months post randomization ]

2.  Secondary:   Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)   [ Time Frame: Baseline to 6 months post randomization ]

3.  Secondary:   Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants   [ Time Frame: At 6 and 12 months post randomization ]

4.  Secondary:   Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization   [ Time Frame: At 6 and 12 months post randomization ]

5.  Secondary:   Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants   [ Time Frame: Month 12 ]

6.  Secondary:   Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12   [ Time Frame: 12 Months post randomization ]

7.  Secondary:   Percentage of Participants With New Onset Diabetes Mellitus - All Randomized Participants   [ Time Frame: Month 12 post randomization ]

8.  Secondary:   Number of Participants With Anti-Donor Human Leukocyte Antigen (HLA) Positive Antibodies   [ Time Frame: Month 6 and Month 12 Post Randomization ]

9.  Secondary:   Mean Change From Baseline to Month 6 and to Month 12 in Serum Creatinine - All Randomized Participants   [ Time Frame: Baseline to Month 6 and Month 12 Post Randomization ]

10.  Secondary:   Number of Participants With Serious Adverse Events (SAEs), Deaths, and Discontinuation Due to Adverse Events (AEs) From First Dose up to Month 12   [ Time Frame: First Dose (Day 1) to Month 12 ]

11.  Secondary:   Mean Change From Baseline in SF-36 Questionnaire Physical Component Score and in Mental Component Score at Month 12 - All Randomized Participants   [ Time Frame: Baseline, Month 12 ]

12.  Secondary:   Mean Change From Baseline to Month 12 for Eight Domain Scores of Quality of Life (QoL) Instrument SF-36 - All Randomized Participants   [ Time Frame: Baseline (screening) to Month 12 ]

13.  Secondary:   Ridit Score at Month 12 - All Randomized Participants   [ Time Frame: Month 12 ]

14.  Secondary:   Number of Participants Meeting Marked Laboratory Abnormality Criteria From Baseline up to Month 12 - Randomized and Treated Participants   [ Time Frame: Baseline up to Month 12 ]

15.  Secondary:   Long Term Period: Mean Change From Baseline to 54 Months Post Randomization in Calculated GFR on Imputed Values at Specified Timepoints - Intent to Treat (ITT) Participants Who Entered LT Period   [ Time Frame: Baseline, Month 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 ]

16.  Secondary:   Long Term Period: Number of Participants With Acute Rejection (AR) - All Randomized Participants in LT Period   [ Time Frame: Post Month 12 up to Year 6 of the Study ]

17.  Secondary:   Long Term Period: Number of Participants Who Survived With a Functioning Graft or Survived With Pure Graft Loss or Death With Functioning Graft - ITT Participants Who Entered the LT Period   [ Time Frame: Post Months 24, 36, 48, up to Year 6 of the Study ]

18.  Secondary:   Long Term Period: Percentage of Participants With New Onset Diabetes Mellitus Up to Month 36- All Randomized Participants Who Entered LT Period   [ Time Frame: Baseline (screening) up to Month 36 post randomization ]

19.  Secondary:   Long Term Period: Number of Participants With SAEs, Death, Discontinuation Due to AEs - All Randomized Participants Who Entered the Long Term Period   [ Time Frame: First dose after randomization (Day 1) to 56 days post last dose, up to Year 6 of the Study ]

20.  Secondary:   Long Term Period: Number of Participants With AEs of Special Interest - All Randomized Participants Who Entered the Long Term Period   [ Time Frame: First dose after randomization (Day 1) to last dose, plus 56 days, up to Year 6 of the Study ]

21.  Secondary:   Long Term Period: Mean Change From Baseline to Month 54 in Serum Creatinine- ITT Participants Who Entered LT Period   [ Time Frame: Baseline, Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54 ]

22.  Secondary:   Long Term Period: Number of Participants Meeting Marked Laboratory Abnormality Criteria - All ITT Participants Who Entered the Long Term Period   [ Time Frame: Baseline (Screening), up to Year 6 of the Study ]

23.  Secondary:   Long Term Period: Mean Change From Baseline to Month 54 in Systolic Blood Pressure   [ Time Frame: Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54 ]

24.  Secondary:   Long Term Period: Mean Change From Baseline to Month 54 in Diastolic Blood Pressure   [ Time Frame: Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54 ]

25.  Secondary:   Participants Who Switched From CNI to Belatacept in Long Term Period : Mean Change in Calculated GFR Based on Imputed Values From Day of Switch to Week 96 Post Switch   [ Time Frame: Day of Switch (first belatacept dose) to Week 96 Post Switch ]

26.  Secondary:   Participants Who Switched to Belatacept in Long Term Period: Number of Participants With AEs and SAEs   [ Time Frame: Day of Switch (first dose of belatacept ) to last dose plus 56 days, up to Year 6 of the Study ]


  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
CNI arm discontinued Year 3, and those not switching treatment discontinued from study. No formal comparisons in calculated GFR were planned post Month 36, and these data up to the final database lock should be interpreted with caution.


  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


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

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00402168     History of Changes
Other Study ID Numbers: IM103-010
LEA29Y
Study First Received: November 20, 2006
Results First Received: November 10, 2015
Last Updated: November 7, 2016