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A Study of Belimumab in the Prevention of Kidney Transplant Rejection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01536379
First received: February 16, 2012
Last updated: March 14, 2017
Last verified: March 2017
Results First Received: October 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Transplantation, Organ
Interventions: Drug: Belimumab
Drug: Placebo

  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
A total of 30 renal transplant recipients were enrolled, of which 28 were randomized and 25 were transplanted.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized to 1 of the 2 treatments groups in a 1:1 ratio and received standard of care in addition to investigational products (IPs). Participants received IP infusion on Day 0, Day 14, Day 28 and every 4 weeks thereafter for a total of 7 infusions.

Reporting Groups
  Description
Placebo Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Belimumab 10mg/kg Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

Participant Flow:   Overall Study
    Placebo   Belimumab 10mg/kg
STARTED   13   12 
COMPLETED   11   9 
NOT COMPLETED   2   3 
Adverse Event                1                2 
Withdrawal by Subject                1                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.
No text entered.

Reporting Groups
  Description
Placebo Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Belimumab 10mg/kg Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
Total Total of all reporting groups

Baseline Measures
   Placebo   Belimumab 10mg/kg   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   12   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.0  (14.02)   54.3  (11.02)   52.6  (12.52) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  30.8%      7  58.3%      11  44.0% 
Male      9  69.2%      5  41.7%      14  56.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White/Caucasian   12   11   23 
Asian   1   1   2 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in naïve B Cells From Baseline to Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)   [ Time Frame: Up to 1 year ]

3.  Primary:   Number of Incidence of All Infections and Serious Infections   [ Time Frame: Up to 1 year ]

4.  Primary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

5.  Primary:   Change From Baseline in Heart Rate From Baseline at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

6.  Primary:   Change From Baseline in Body Temperature From Baseline at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

7.  Primary:   Number of Participants Outside the Normal Range (NR) for SBP and DBP at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

8.  Primary:   Number of Participants Outside the Normal Range (NR) for Heart Rate at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

9.  Primary:   Number of Participants Outside the Normal Range (NR) for Body Temperature at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

10.  Primary:   Change From Baseline in the Indicated Hematology Parameters at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

11.  Primary:   Change From Baseline in the Haematology Parameter- Hemoglobin at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

12.  Primary:   Change From Baseline in the Hematology Parameter- Hematocrit at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

13.  Primary:   Change From Baseline in Haematology Parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

14.  Primary:   Change From Baseline in Haematology Parameter- Mean Corposcular Volume (MCV) at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

15.  Primary:   Change From Baseline in Haematology Parameter- Red Blood Cell (RBC) at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

16.  Primary:   Change From Baseline in Clinical Chemistry Parameter- Albumin at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

17.  Primary:   Change From Baseline in Clinical Chemistry Parameter- ALP, ALT, AST at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

18.  Primary:   Change From Baseline in Clinical Chemistry Parameter- Direct Bilirubin, Total Bilirubin and Creatinine at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

19.  Primary:   Change From Baseline in Clinical Chemistry Parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

20.  Primary:   Change From Baseline in Clinical Chemistry Parameter- Glomerular Filtration Rate (GFR) at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

21.  Primary:   Change From Baseline in Immunoglobulin A (IgA), Immunoglobulin G (IgG) and Immunoglobulin M (IgM) at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

22.  Secondary:   Median Percent Change From Baseline in Memory B Cell Count at Week 24 and Week 52   [ Time Frame: Baseline, Week 24 and Week 52 ]

23.  Secondary:   Activated Memory B Cells Count at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

24.  Secondary:   Activated Memory B Cells Percentage at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

25.  Secondary:   Transitional B Cells Count at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

26.  Secondary:   Transitional B Cells Percentage at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

27.  Secondary:   Activated T Cell Count at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

28.  Secondary:   Activated T Cell Percentage at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

29.  Secondary:   Regulatory T Cell Count at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

30.  Secondary:   Regulatory T Cell (%CD4) at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

31.  Secondary:   Mean Activated: Regulatory T Cell Ratio at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

32.  Secondary:   Proportion of Participants With Episodes of Acute Rejection at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

33.  Secondary:   Mean Serum Creatinine at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

34.  Secondary:   Mean eGFR at Week 24 and Week 52   [ Time Frame: Week 24 and Week 52 ]

35.  Secondary:   Mean Prednisolone Use at Week 24   [ Time Frame: Week 24 ]


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01536379     History of Changes
Other Study ID Numbers: 114424
Study First Received: February 16, 2012
Results First Received: October 5, 2016
Last Updated: March 14, 2017