1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response (Others) -  We commit to share patient-level data, study-level data, CSRs, and protocols with qualified scientific researchers.


4. For what types of analyses will this data be available?
   Response (Others) -  For those purposes as explained in the ICF


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [DataSharing@biogen.com].
   


6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
   Response (Others) -  18 months post-LPO and to Vivli.org


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Transparency in clinical trials

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body’s own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys.

Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure.

In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease.

The main question that researchers want to answer is:

- How many participants achieve a complete response after 104 weeks of treatment?

- A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.

Researchers will also learn about:

- How long it takes before the participants’ disease gets worse

- How long the participants’ urine protein levels stay low

- How many participants develop antibodies against felzartamab in the blood?

- How many participants achieve a complete response after 76 weeks of treatment

- How many participants have medical problems during the study

- How felzartamab is processed by the body

- How felzartamab affects participants’ tiredness and overall physical health

The study will be done as follows:

- Participants will be screened to check if they can join the study. This may take up to 42 days.

- Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.

- If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment.

- If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.

- In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.