Belimumab With Rituximab for Primary Membranous Nephropathy
Status:
Recruiting
Trial end date:
2026-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the effectiveness of belimumab and
intravenous rituximab co-administration at inducing a complete remission (CR) compared to
rituximab alone in participants with PM.
Background:
Primary membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in
adults. MN affects individuals of all ages and races. The peak incidence of MN is in the
fifth decade of life.
Primary MN is recognized to be an autoimmune disease, a disease where the body's own immune
system causes damage to kidneys. This damage can cause the loss of too much protein in the
urine.
Drugs used to treat MN aim to reduce the attack by one's own immune system on the kidneys by
blocking inflammation and reducing the immune system's function. These drugs can have serious
side effects and often do not cure the disease. There is a need for new treatments for MN
that are better at improving the disease while reducing fewer treatment associated side
effects.
In this study, researchers will evaluate if treatment with a combination of two different
drugs, belimumab and rituximab, is effective at blocking the immune attacks on the kidney
compared to rituximab alone. Rituximab works by decreasing a type of immune cell, called B
cells. B cells are known to have a role in MN. Once these cells are removed, disease may
become less active or even inactive. However, after stopping treatment, the body will make
new B cells which may cause disease to become active again.
Belimumab works by decreasing the new B cells produced by the body and, may even change the
type of new B cells subsequently produced. Belimumab is approved by the US Food and Drug
Administration (FDA) to treat systemic lupus erythematosus (also referred to as lupus or
SLE). Rituximab is approved by the FDA to treat some types of cancer, rheumatoid arthritis,
and vasculitis. Neither rituximab nor belimumab is approved by the FDA to treat MN. Treatment
with a combination of belimumab and rituximab has not been studied in individuals with MN,
but it is currently being tested in other autoimmune diseases, including lupus nephritis and
Sjögren's syndrome.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
GlaxoSmithKline Immune Tolerance Network (ITN) PPD Rho Federal Systems Division, Inc.