This study involves people with Primary Membranous Nephropathy, a kidney disease where the filtering units of the kidneys become damaged and thickened, leading to protein leaking into the urine. The study will test a treatment called ALPN-303, which is also known as povetacicept, and compare it to a standard treatment called a calcineurin inhibitor, which in this study is tacrolimus. Povetacicept is given as an injection under the skin, while tacrolimus is taken by mouth as a capsule. The purpose of the study is to find out how well povetacicept works in treating this kidney condition and to check how safe it is.
Participants will be randomly assigned to receive either povetacicept or tacrolimus. The study will last up to 72 weeks, during which time participants will receive their assigned treatment and attend regular visits for monitoring. During these visits, various tests will be performed to check kidney function, measure protein levels in the urine, and monitor overall health. Blood tests, heart tracings, and other measurements will be taken to ensure the treatments are working properly and to watch for any unwanted effects.
The main goal is to see how many participants achieve complete remission of their kidney disease, which means their kidney function has improved and the amount of protein in their urine has decreased to normal or near-normal levels. The study will also look at different definitions of improvement and will carefully track any side effects or health changes that occur during treatment. This information will help doctors understand whether povetacicept could be a useful treatment option for people with this type of kidney disease.
Czechia 
Germany 
Hungary 
Ireland 
Italy 
Spain 
The Netherlands 
