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A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01610492
First Posted: June 4, 2012
Last Update Posted: October 13, 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):
GlaxoSmithKline
Results First Submitted: May 11, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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
Eligible participants were recruited from July 2012 until March 2014, into this 2 part study of a initial treatment phase, a long term treatment phase, and then followed up for a further 6 months. Results have previously been presented for the initial treatment phase, up to the Week 28 and are now presented for the completed study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening occurred within 35 days and no less than 14 days before the first scheduled study treatment dose. Total 21 participants were screened; 14 were randomized and entered the initial treatment phase while 11 participants entered the long-term treatment phase. 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 at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.

Participant Flow:   Overall Study
    Belimumab 10 mg/kg IV
STARTED   14 
COMPLETED   8 
NOT COMPLETED   6 
Adverse Event                1 
Lack of Efficacy                3 
Other: Reached stopping criteria                1 
Other:Treatment stopped due to remission                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 at Week 0 Week 2 and Week 4, then every 4 weeks over 24 weeks. Participants then entered the long-term phase of the study and received belimumab 10 mg/kg every 4 weeks up to Week 100 or until complete remission had been achieved.

Baseline Measures
   Belimumab 10 mg/kg IV 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.1  (13.30) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  21.4% 
Male      11  78.6% 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian - Central/South Asian Heritage   4 
White- White/Caucasian/European Heritage   9 
Unknown   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 Titers at Week 28   [ Time Frame: Baseline and Week 28 ]

3.  Secondary:   Proteinuria Levels at the Indicated Time Points   [ Time Frame: Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up ]

4.  Secondary:   Change From Baseline in Proteinuria Levels at the Indicated Time Points   [ Time Frame: Baseline and Week 12, 28, 52, 76, 104 and Week 128/6 month follow up ]

5.  Secondary:   Anti-phospholipase A2 Receptor (PLA2R) Autoantibody Levels at Indicated Time Points   [ Time Frame: Baseline and Week 12, 28, 52, 76, 104 and 128/6 month follow-up ]

6.  Secondary:   Change From Baseline in Anti-PLA2R Autoantibody Titers at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128. ]

7.  Secondary:   Number of Participants With Complete or Partial Remission   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128 ]

8.  Secondary:   Time to Complete or Partial Remission   [ Time Frame: Baseline and up to Week 128/6 month follow up ]

9.  Secondary:   Duration of Complete or Partial Remission   [ Time Frame: Baseline and up to Week 128/6 month follow up ]

10.  Secondary:   Number of Participants With PLA2R Autoantibody Remission   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128 ]

11.  Secondary:   Time to Anti-PLA2R Autoantibody Remission   [ Time Frame: Baseline and up to Week 128/6 month follow up ]

12.  Secondary:   Number of Participants With Anti-PLA2R Autoantibody Relapse   [ Time Frame: Baseline and up to Week 128/6 month follow up ]

13.  Secondary:   eGFR Levels at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up. ]

14.  Secondary:   Change From Baseline in eGFR Levels at the Indicated Time Points   [ Time Frame: Baseline and up to Week 128/6 month follow up ]

15.  Secondary:   Serum Creatinine Levels at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up ]

16.  Secondary:   Change From Baseline in Serum Creatinine Levels at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up ]

17.  Secondary:   Serum Albumin Levels at Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up. ]

18.  Secondary:   Change From Baseline in Levels of Serum Albumin at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up ]

19.  Secondary:   Serum Cholesterol Levels at Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up ]

20.  Secondary:   Change From Baseline in Serum Cholesterol at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up ]

21.  Secondary:   Serum Immunoglobulin G (IgG) Levels at Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow-up ]

22.  Secondary:   Change From Baseline in Serum IgG at the Indicated Time Points   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, 104 and 128/6 month follow up ]

23.  Secondary:   Number of Participants With Edema and Edema Extending Beyond Calf   [ Time Frame: Baseline and Weeks 12, 28, 52, 76, and 104 ]

24.  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 ]

25.  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 ]

26.  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 ]

27.  Secondary:   Summary of Total Amount of Urine Excreted Ae(0-24)   [ Time Frame: Baseline and Up to 4 week post last dose ]

28.  Secondary:   Change From Baseline in Short Form (SF)-36 v2 Quality of Life (QoL) Questionnaire Score   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]

29.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline and up to Week 128/6 month follow up ]

30.  Secondary:   Number of Participants With Abnormal Clinical Chemistry and Hematology Values   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]

31.  Secondary:   Number of Participants With Urinalysis Dipstick Findings   [ Time Frame: Baseline and up to Week 116/16 Week follow up ]

32.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline and up to week 116/16 week follow-up visit ]

33.  Secondary:   Change From Baseline in Pulse Rate   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]

34.  Secondary:   Change From Baseline in Temperature   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]

35.  Secondary:   Number of Participants With Positive Immunogenicity Findings   [ Time Frame: Baseline and up to Week 116/16 week follow-up visit ]

36.  Secondary:   Urine Membrane Attack Complex (MAC) Levels   [ Time Frame: Baseline and up to 4 week post last dose ]

37.  Secondary:   Change From Baseline in Urine Membrane Attack Complex (MAC)   [ Time Frame: Baseline and up to 4 week post last dose ]

38.  Secondary:   Change From Baseline in B Cell and T Cell Markers Concentration   [ Time Frame: Baseline and up to Week 128/6 month post last dose ]

39.  Secondary:   Change From Baseline in Cytokines/Chemokine   [ Time Frame: Baseline and up to Week 104/4 week post last dose ]

40.  Secondary:   Serum BLys Levels   [ Time Frame: Baseline and Week 116/16 week follow-up visit ]

41.  Secondary:   Urine BLys Levels as a Ratio to Creatinine   [ Time Frame: Baseline and Week 116/16 week follow-up visit ]


  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: NCT01610492     History of Changes
Other Study ID Numbers: 116472
First Submitted: May 31, 2012
First Posted: June 4, 2012
Results First Submitted: May 11, 2015
Results First Posted: June 1, 2015
Last Update Posted: October 13, 2017