Efficacy and Safety Study of Intravenous Belimumab Versus Placebo in Subjects With Idiopathic Membranous Nephropathy
Status:
Withdrawn
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
The main clinical study will be a randomized, double-blind, placebo-controlled, long term
study involving a 100 week treatment period. The purpose of this study is to test for
superiority of treatment with belimumab 10 mg/kg plus supportive therapy compared to placebo
plus supportive therapy in idiopathic membranous nephropathy (IMN). The purpose of this study
is also to investigate the effect of initiating earlier treatment with belimumab compared to
delayed treatment with current immunosuppressive treatment regimens. The study will also
determine the pharmacokinetic (PK) profile of belimumab and further explore the mechanism of
action of Belimumab as well as effects on quality of life. All subjects (on either active
treatment or placebo) will receive background supportive therapy throughout the main clinical
study, which includes angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin
receptor blockers (ARBs) unless contraindicated and may include statins, diuretics, dietary
salt restriction but excludes immunosuppressants (except low dose corticosteroids). Screening
will be done within 5 to 2 weeks before the first scheduled dose of study treatment. A total
of 94 evaluable subjects will be randomized in a 1:1 ratio such that 47 subjects receive
intravenous belimumab 10 mg/kg and 47 receive intravenous placebo. Subjects will be dosed on
Days 0, 14, 28 and then every 4 weeks through to, and including, Week 100, resulting in a
total of 27 doses (giving 104 weeks of drug exposure). 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 1000mg/mmol (greater than 10 g/24 h), to compensate for loss of
belimumab in the urine. Subjects who are withdrawn from study treatment at any time during
the study, eg for rescue therapy, will participate in follow-up visits every 12 weeks up to
week 104. A subject will be regarded as having completed the main clinical study if they
complete all phases of the main clinical study (screening, treatment period, 4 week and 16
week post last dose short term safety follow-up). Subjects who complete the main clinical
study will therefore participate in the main clinical study for approximately 28 months.
After the main clinical study, there will be a 5 year (long term) follow-up phase to assess
long term outcomes.