A Study of Belimumab in Idiopathic Membranous Glomerulonephropathy
Status:
Completed
Trial end date:
2016-09-14
Target enrollment:
Participant gender:
Summary
This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety
and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R)
autoantibody positive idiopathic membranous glomerulonephropathy (IMGN), and to profile the
relationship between biomarkers, autoantibody status and clinical response. 10 milligrams per
kilogram (mg/kg) belimumab intravenous (IV) will be administered at weeks 0, 2, and then
every 4 weeks, over a 24-week treatment period in subjects with anti-PLA2R antibody positive
IMGN followed by a further long term treatment period until subjects reach remission of
proteinuria, up to a maximum of 2 years total treatment. All subjects will receive background
supportive therapy throughout the study. The dosing frequency will be adjusted to every 2
weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is
greater than 1000 milligrams per millimole (mg/mmol) [greater than 10 grams(g)/24 hours (h)],
to compensate for loss of belimumab in the urine. Effects on mechanistic markers will be
measured by the level of proteinuria, levels of anti-PLA2R antibodies, and various other
measures of kidney function. These will be compared to historical data. The pharmacokinetics
of belimumab will be measured to confirm dosing in heavily proteinuric subjects.
Pharmacodynamic (PD) markers, biomarkers and Quality of Life(QoL) in IMGN subjects will also
be investigated. Safety will be assessed by adverse events (AE), clinical laboratory
evaluations, and vital signs.