Gazyva for Membranous Nephropathy, What the 37% Remission Result Means for Your Next Treatment

Rituximab is a lymphoma and arthritis drug that kidney guidelines list among the main medicines for primary membranous nephropathy, even though it was never approved for it. No medicine has ever been FDA-approved specifically for this disease, so rituximab and tacrolimus are prescribed off label for it. That could change soon, since the FDA is due to decide by November 2026 whether Gazyva (obinutuzumab) becomes the first approved treatment, according to Genentech. An approval would give you a drug whose dosing, warnings and coverage rules are written for this disease. Your nephrologist would still weigh it against the plan you are on now.

What Primary Membranous Nephropathy Does to the Kidneys

Primary membranous nephropathy is an autoimmune disease in which the immune system makes antibodies against the kidney's own filters. In about 70% of people, the target is a protein called PLA2R (Beck et al., NEJM 2009). PLA2R sits on podocytes, the cells that wrap the tiny blood vessels where urine is made. The antibodies pile up along the filter wall, and protein that belongs in the blood leaks into the urine instead.

About 12 people in every million are diagnosed each year in North America, most often between the ages of 50 and 60 (National Kidney Foundation and NephCure, 2023). Swollen ankles and foamy urine are usually the first signs. Without treatment, about a third of people go into remission on their own. Another third keep leaking some protein with a good outlook, and the last third often move toward kidney failure, according to the same report.

The numbers leave out what daily life feels like, which patients described to FDA staff at a 2021 meeting held by the National Kidney Foundation and NephCure. Patients described carrying extra fluid, in one case up to 24 pounds in 24 hours. Others described tiredness with "brain fog" that made work or school hard, and a constant fear of dialysis (Voice of the Patient report, 2023).

In the Phase 3 MAJESTY trial, 37% of adults with primary membranous nephropathy were in complete remission 2 years after starting Gazyva (Fervenza et al., NEJM 2026). On tacrolimus, an anti-rejection pill used off label in this disease, the figure was 6%.

Complete remission meant a urine protein-to-creatinine ratio of 0.3 g/g or lower, close to normal, with stable kidney function. The trial counted 26 of 71 people on Gazyva and 4 of 70 on tacrolimus. After adjusting for missing data, Gazyva led by 31 percentage points, and the trial's 95% confidence interval ran from 18 to 44 points.

Everyone in MAJESTY started with a lot of protein to lose. Entry required at least 5 g/g of protein after 3 months of blood pressure medicine and other supportive care, or at least 4 g/g after 6 months (ClinicalTrials.gov NCT04629248). Gazyva was given as 4 infusions of 1,000mg at weeks 0, 2, 24 and 26. Tacrolimus was taken twice a day for up to a year and then tapered over 8 weeks. By design, it had stopped at least 10 months before the 2-year check.

Gazyva also came out ahead on 2 other goals, remission of any kind at 2 years and complete remission at 76 weeks. The next goal on the trial's ranked list was preventing a lasting 30% drop in kidney function. On that goal the difference was not clear enough to count (NEJM). Under the trial's rules, the goals after that one were not formally tested. MAJESTY was also open label, meaning patients and doctors knew which drug each person received.

Serious side effects were about as common on both drugs, 17% on Gazyva and 14% on tacrolimus (NEJM). Infections ran at 61 per 100 patient-years on Gazyva and 57 on tacrolimus, counting every year each person spent in the trial. The investigators listed infusion reactions, airway infections and low white blood cell counts as the side effects tied to Gazyva. One person in each group died during the trial's rescue phase, and the published summary does not give a cause.

Gazyva or Rituximab for Membranous Nephropathy?

No study has compared Gazyva with rituximab in membranous nephropathy, so nobody can say from trial data that one works better than the other. Both are antibodies that remove B cells, the immune cells that make anti-PLA2R antibodies, by latching onto a marker called CD20.

The strongest rituximab evidence comes from MENTOR, a 2019 trial of 130 adults led by Dr. Fernando Fervenza of the Mayo Clinic, who also led MAJESTY. Rituximab kept 60% of people in complete or partial remission at 2 years, against 20% on cyclosporine, another anti-rejection pill (NEJM 2019). Gazyva is built differently, and Genentech describes it as a type II antibody designed to kill B cells more directly, including B cells sitting in tissue.

The forest plot above shows why the 2 results cannot be ranked. MENTOR counted any remission against cyclosporine, while MAJESTY counted only complete remission against tacrolimus. Rituximab is also sold in several biosimilar versions, so insurance rules may shape which drug a doctor can prescribe once Gazyva has a label.

Other Gazyva studies in this disease are under way abroad. A Phase 3 trial at Huashan Hospital in Shanghai is comparing obinutuzumab with cyclophosphamide and steroids, the older standard (NCT06781944). A smaller single-group study at Radboud University Medical Center in the Netherlands is tracking how fast Gazyva clears PLA2R antibodies (NCT07163611).

Who Might Get Gazyva First, Judging by Who Was in MAJESTY

The FDA label will define who Gazyva is for if it is approved, and that wording is not public yet. The closest guide is the MAJESTY entry list on ClinicalTrials.gov, because a label often follows the people a drug was tested in.

• Adults with primary membranous nephropathy confirmed by a kidney biopsy
• Urine protein of at least 5 g/g after 3 months of supportive care, or 4 g/g after 6 months
• An eGFR of 40 or higher, so kidney function was still fairly well preserved
• No diabetes, no active infection, and not pregnant or breastfeeding
• No rituximab or other anti-CD20 drug in the previous 9 months, and no tacrolimus, cyclosporine or cyclophosphamide in the previous 6

The 4 situations below show how those rules might play out, and each is a composite written for this guide rather than a real patient.

Newly diagnosed, with heavy protein and good kidney function

Picture someone diagnosed this spring with a high anti-PLA2R level and an eGFR of 75. After 3 months on an ACE inhibitor they still lose 7 g/g of protein, which looks like the people MAJESTY enrolled. The question for the nephrologist is whether to start rituximab now or plan around the FDA decision. Heavy protein loss carries its own risks, including blood clots, so a wait is a medical judgment rather than a default.

Already on tacrolimus with only a partial response

MAJESTY excluded anyone who had taken tacrolimus in the previous 6 months, so the trial says nothing direct about switching from it. That makes switching a fair question to raise with your doctor rather than a yes or no from the data.

Protein back after rituximab worked once

People whose disease returns after earlier treatment are not shut out of research. Biogen's Phase 3 trial of felzartamab accepts people with relapsed membranous nephropathy (NCT06962800), and MAJESTY required at least 9 months since the last anti-CD20 dose.

Well-controlled diabetes or kidney function below 40

Anyone with diabetes was ruled out of MAJESTY. Amgen's new Phase 3 trial of inebilizumab does accept people whose HbA1c is under 7.5%, if a recent biopsy rules out diabetic kidney disease (NCT07851220). Both trials exclude an eGFR under 40. Biogen's felzartamab trial sets its cutoff lower and excludes only an eGFR of 30 or below (NCT06962800), so it is worth asking about if yours sits between 31 and 39.

What a Gazyva Infusion Involves, From Premedicines to Hepatitis B Checks

In MAJESTY, each Gazyva dose was a 1,000mg infusion into a vein at weeks 0, 2, 24 and 26 (ClinicalTrials.gov). That adds up to 4 visits over about 6 months. People received 3 premedicines 30 to 60 minutes before each infusion. They were 80mg of methylprednisolone, a steroid, plus acetaminophen and the antihistamine diphenhydramine. Gazyva's lupus nephritis label, the closest guide today, allows a shorter 90-minute infusion from the second dose for eligible patients (FDA label).

Gazyva carries a boxed warning, the FDA's strongest kind, for hepatitis B coming back and for PML (FDA label). PML is a rare and serious brain infection, and the hepatitis B risk is why doctors test for it before the first dose. Live vaccines are avoided during treatment. Genentech advises effective birth control during treatment and for 6 months after the last dose.

Anyone planning a pregnancy may want to map that 6-month window onto a calendar before the first infusion. Women at the 2021 FDA meeting described the clash between current treatments and pregnancy as a significant concern (Voice of the Patient report, 2023).

Membranous Nephropathy Trials Enrolling in the US, and Why Tacrolimus Keeps Showing Up

Of the 4 Phase 3 or Phase 2/3 membranous nephropathy trials now enrolling in the United States, 3 test their drug against tacrolimus, the same comparator MAJESTY used. Trial Friend found this by reading each ClinicalTrials.gov record on October 23, 2026.

Biogen's felzartamab trial has 16 US sites (NCT06962800), and Amgen's inebilizumab trial lists 4 so far (NCT07851220). Vertex's povetacicept trial has the most, with 27 (NCT07204275). The fourth, Cerium Pharmaceuticals' trial of an injected hormone gel called SNP-ACTH, compares it with rituximab at 19 US sites (NCT05696613). All 3 tacrolimus-comparator trials measure success the way MAJESTY did, as complete remission at 2 years.

For someone thinking about joining, this matters in a practical way. In a trial against tacrolimus, some participants are assigned tacrolimus, given on a schedule set by that trial. Ask the study team how many people get the comparator and what rescue treatment is offered if protein stays high. Ask too whether the plan changes if Gazyva is approved during the study.

Counting every enrolling study, Trial Friend found 46 recruiting or soon-to-recruit interventional studies listing membranous nephropathy on ClinicalTrials.gov. That count includes the 4 above, and 14 of the 46 had at least 1 US site. They include an NIH-funded study adding belimumab to rituximab at 20 US sites (NCT03949855). The University of Michigan's NEPTUNE Match study works differently and is open at 16 US sites (NCT04571658). It pairs people already in the NEPTUNE research study with trials that fit their biology. The membranous nephropathy trials page keeps the live list.

Help Paying for Gazyva, and the Advocates Behind This FDA Review

Genentech Access Solutions handles insurance questions for Gazyva at 866-422-2377. Its co-pay program lets eligible people with commercial insurance pay as little as $0. It covers up to $15,000 a year for the drug and $2,000 for infusion costs. Those terms come from the Gazyva lupus nephritis site as checked on October 12, 2026, so confirm them for membranous nephropathy after the FDA decides. Uninsured people may qualify for free medicine through the Genentech Patient Foundation.

Patients have been building the record for this moment for years. In August 2021, the National Kidney Foundation and NephCure held a patient-focused drug development meeting, a session where patients speak directly to FDA staff. Of the 267 people who watched, 112 were patients or care partners (Voice of the Patient report, 2023).

Many said the side effects of today's off-label treatments were "often worse than the disease itself." They asked for treatments aimed at the disease rather than the whole immune system. The report was written for the FDA to use when it weighs new membranous nephropathy treatments. NephCure focuses on rare protein-spilling kidney diseases and ran a 2023 workshop on using anti-PLA2R antibody levels to design trials (Prunotto and colleagues, 2025).

Both groups offer practical help today. NKF Cares answers calls at 855-653-2273 on weekdays, and the NKF PEERS program pairs patients by phone with trained mentors who have lived with kidney disease. NephCure offers one-on-one patient support, support groups and a directory for finding a kidney specialist.

What Happens After the FDA Rules on Gazyva for Membranous Nephropathy

Genentech has said only that a decision is expected by November 2026, under priority review and with Breakthrough Therapy designation granted in April 2026. If Gazyva is approved, the label will set who qualifies and how often it is given, and insurers will write their own coverage rules afterward. If the FDA asks for more information instead, rituximab and the other off-label options stay where they are.

The Trial Friend FDA calendar entry for Gazyva will show the decision the day it lands. If you want one email when it does, use the signup below.

The thread behind this decision runs back to a Boston lab in 2009, when Laurence Beck and David Salant reported that most people with this disease make antibodies against PLA2R. That finding gave doctors their first blood test aimed at the cause (New England Journal of Medicine, 2009). In 2021, Dr. Beck co-chaired the patient meeting with the FDA, and MAJESTY sorted its patients by that same antibody level before deciding who got which drug.

What Patients Are Asking About Gazyva for Membranous Nephropathy