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MinorEligibility criteria expanded, about 52 wordsSecondary endpoints: details revised at 1 of 15 entries · Site contacts updated at 1 of 20 sites · Publications: details revised at 1 of 1 entry · 1 moreShow 4 more changesShow less
Secondary endpoints: details revised at 1 of 15 entries
Site contacts updated at 1 of 20 sites
Publications: details revised at 1 of 1 entry
Study description expanded, about 3 words
MinorSite contacts updated at 3 of 20 sitesv40
MinorSite contacts updated at 1 of 20 sitesv39
MinorSite contacts updated at 1 of 20 sitesv38
MinorSite contacts updated at 2 of 20 sitesv37
Show 35 earlier versionsHide 35 earlier versions
MinorSite contacts updated at 1 of 20 sitesv36
MinorSite contacts updated at 1 of 20 sitesv35
MinorSite contacts updated at 1 of 20 sitesv34
MinorStudy sites: 19 to 20v33
MinorSite details revised at 1 of 19 sitesv32
MinorSite details revised at 2 of 19 sitesv31
MinorSite details revised at 1 of 19 sitesv30
MinorStudy sites: 22 to 19v29
MinorSite details revised at 11 of 22 sitesv28
NotableTrial status: Active, Not Recruiting to RecruitingStudy sites revised (22)v27Show 1 more changeShow less
NotablePrimary completion date: Oct 2025 to Mar 1, 2029Start date: Dec 18, 2019 to Mar 6, 2020 · Completion date: Oct 2026 to Mar 1, 2030v23Show 2 more changesShow less
Start date: Dec 18, 2019 to Mar 6, 2020
Completion date: Oct 2026 to Mar 1, 2030
MinorStudy sites: 21 to 22v22
MinorTrial status: Recruiting to Active, Not RecruitingEligibility criteria expanded, about 101 words · Secondary endpoints: 14 to 15 · Study description expanded, about 365 words · 1 morev21Show 4 more changesShow less
NotablePrimary completion date: May 2024 to Oct 2025Completion date: Feb 2025 to Oct 2026 · Site details revised at 1 of 17 sitesv13Show 2 more changesShow less
Completion date: Feb 2025 to Oct 2026
Site details revised at 1 of 17 sites
MinorSite details revised at 1 of 17 sitesv12
MinorSite details revised at 2 of 17 sitesv11
MinorStudy sites: 16 to 17v10
MinorSite details revised at 3 of 16 sitesv9
MinorSite details revised at 1 of 16 sitesv8
MinorSite details revised at 1 of 16 sitesv7
MinorSite details revised at 1 of 16 sitesv6
NotableTrial status: Not Yet Recruiting to RecruitingStart date: Dec 2019 to Dec 18, 2019 · Site details revised at 16 of 16 sitesv5Show 2 more changesShow less
Start date: Dec 2019 to Dec 18, 2019
Site details revised at 16 of 16 sites
MinorStart date: Nov 2019 to Dec 2019Study sites revised (16)v4Show 1 more changeShow less
NotableStart date: Sep 2019 to Nov 2019Primary completion date: Mar 2024 to May 2024 · Completion date: Dec 2024 to Feb 2025v3Show 2 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The primary objective of this study is to evaluate the effectiveness of belimumab and intravenous rituximab co-administration at inducing a complete or partial remission (CR or PR) compared to rituximab alone in participants with primary membranous nephropathy.
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 has been tested in other autoimmune diseases, including lupus nephritis and Sjögren's syndrome.