A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01610492
First received: May 31, 2012
Last updated: May 11, 2015
Last verified: April 2015
Results First Received: May 11, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Glomerulonephritis, Membranous
Intervention: Drug: belimumab

  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
Participants (par.) were recruited into the initial 6 month treatment phase of this 2 part study from July 2012 until March 2014 in academic nephrology clinics. Results presented are for the initial treatment phase, up to the Week 28 primary endpoint.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening occurred within approximately 35 days and no less than 14 days before the first scheduled dose of study medication. A total of 21 participants were screened; 14 participants were randomized, and 14 participants entered the initial treatment period. Common reasons for screen failures were insufficient or improvements in proteinuria.

Reporting Groups
  Description
Belimumab 10 mg/kg IV Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.

Participant Flow:   Overall Study
    Belimumab 10 mg/kg IV  
STARTED     14  
COMPLETED     11  
NOT COMPLETED     3  
Lack of Efficacy                 2  
Physician Decision                 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
Belimumab 10 mg/kg IV Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.

Baseline Measures
    Belimumab 10 mg/kg IV  
Number of Participants  
[units: participants]
  14  
Age  
[units: Years]
Mean (Standard Deviation)
  46.1  (13.30)  
Gender  
[units: Participants]
 
Female     3  
Male     11  
Race/Ethnicity, Customized  
[units: Participants]
 
Asian - Central/South Asian Heritage     4  
White     9  
Missing     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Proteinuria Levels at Week 28   [ Time Frame: Baseline and Week 28 ]

2.  Primary:   Change From Baseline in Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titres at Week 28   [ Time Frame: Baseline and Week 28 ]

3.  Secondary:   Proteinuria Levels at the Indicated Time Points   [ Time Frame: Baseline and Week 28 ]

4.  Secondary:   Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Titres at the Indicated Time Points   [ Time Frame: Baseline and Week 28 ]

5.  Secondary:   Change From Baseline in Proteinuria Levels at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76 and 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

6.  Secondary:   Change From Baseline in Anti-PLA2R Autoantibody Titres at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76 and 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

7.  Secondary:   Change From Baseline in Urine Levels of Belimumab at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76 and 4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

8.  Secondary:   Incidence of Complete or Partial Remission   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

9.  Secondary:   Time to Complete or Partial Remission   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

10.  Secondary:   Duration of Complete or Partial Remission   [ Time Frame: Baseline and up to Week 104/ 4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

11.  Secondary:   Incidence of Proteinuria Relapse   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

12.  Secondary:   Incidence of Full/Partial Remission for Anti-PLA2R Autoantibody   [ Time Frame: Baseline and up to Week 104/4 Week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

13.  Secondary:   Time to Anti-PLA2R Autoantibody Remission   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

14.  Secondary:   Incidence of Anti-PLA2R Autoantibody Relapse   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

15.  Secondary:   eGFR Levels at the Indicated Time Points   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

16.  Secondary:   Change From Baseline in eGFR Levels at the Indicated Time Points   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

17.  Secondary:   Serum Creatinine Levels at the Indicated Time Points   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

18.  Secondary:   Change From Baseline in Serum Creatinine Levels at the Indicated Time Points   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

19.  Secondary:   Serum Albumin at the Indicated Time Points   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

20.  Secondary:   Change From Baseline in Levels of Serum Albumin at the Indicated Time Points   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

21.  Secondary:   Cholesterol at the Indicated Time Points   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

22.  Secondary:   Change From Baseline in Levels of Cholesterol at the Indicated Time Points   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

23.  Secondary:   Summary of Incidence of Oedema by Severity   [ Time Frame: Screening and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

24.  Secondary:   Change From Baseline in SF-36 v2 Quality of Life (QoL) Questionnaire Score   [ Time Frame: From Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

25.  Secondary:   Summary of Maximum Observed Serum Concentration (Cmax) of Belimumab at the Indicated Time Points   [ Time Frame: Baseline and up to 4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

26.  Secondary:   Summary of Minimum Observed Concentration (Cmin) of Belimumab at the Indicated Time Points   [ Time Frame: Baseline and up to 4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

27.  Secondary:   Summary of Area Under the Serum Concentration-time Curve to the Last Quantifiable Concentration (AUC[0-2])   [ Time Frame: Baseline and up to 4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

28.  Secondary:   Summary of Total Amount of Urine Excreted Ae(0-24)   [ Time Frame: Baseline and up to 4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

29.  Secondary:   Summary of Clinical Chemistry Laboratory Parameters Assessed up to Week 116/16 Week Post Last Dose   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

30.  Secondary:   Summary of Haematology Laboratory Parameters Assessed up to Week 116/16 Week Post Last Dose   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

31.  Secondary:   Summary of Urinalysis Parameters Assessed up to Week 116/16 Week Post Last Dose   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

32.  Secondary:   Vital Signs Measurements Assessed up to 116/16 Week Follow-up Visit   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

33.  Secondary:   Immunogenicity During the 104-week Treatment Period and up to Week 116/16 Week Follow-up Visit   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

34.  Secondary:   Urine Membrane Attack Complex (MAC)   [ Time Frame: Baseline and up to 4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

35.  Secondary:   Change From Baseline in Urine Membrane Attack Complex (MAC)   [ Time Frame: Baseline and up to 4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

36.  Secondary:   Change From Baseline in B Cell and T Cell Subpopulations   [ Time Frame: Baseline and up to Week 128/6 month post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

37.  Secondary:   Change From Baseline in Cytokines/Chemokines   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

38.  Secondary:   Serum BLys Levels   [ Time Frame: Baseline and Week 116/16 week follow-up visit ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No

39.  Secondary:   Urine BLys Levels as a Ratio to Creatinine   [ Time Frame: Baseline and Week 116/16 week follow-up visit ]
Results not yet reported.   Anticipated Reporting Date:   05/2017   Safety Issue:   No


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01610492     History of Changes
Other Study ID Numbers: 116472
Study First Received: May 31, 2012
Results First Received: May 11, 2015
Last Updated: May 11, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency