Belimumab with Rituximab for Primary Membranous Nephropathy
This study is testing if a combination of two medicines, belimumab and rituximab, is more effective than rituximab alone for adults with primary membranous nephropathy (a kidney disease where your immune system attacks your kidneys, causing protein loss in urine). Researchers want to see if this combination can help more people achieve complete or partial remission (improvement) of their condition. You may be able to join if you are between 18 and 75 years old and have primary membranous nephropathy confirmed by a kidney biopsy. The study aims to enroll 58 participants and will measure how many achieve remission after 104 weeks.
- Study design
- This is an interventional study with an unspecified phase, involving 58 participants. It includes an open-label phase (Part A) where all participants receive belimumab, followed by a comparison of belimumab and rituximab versus rituximab alone.
- What's involved
- Participants in Part A will receive weekly subcutaneous belimumab for 52 weeks, along with two doses of intravenous rituximab at weeks 4 and 6. Blood samples will be taken weekly for the first four doses of belimumab.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed after the 52-week treatment period on no study medication until week 156. The primary outcome is measured at Week 104.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Belimumab With Rituximab for Primary Membranous Nephropathy
At a glance
Conditions
Where it's being run
20 sites across 15 statesStudy leadership
- Patrick Nachman · STUDY_CHAIR · University of Minnesota, Department of Medicine, Division of Renal Diseases and Hypertension
- Iñaki Sanz · STUDY_CHAIR · Emory University, Department of Medicine, Division of Rheumatology
Who to contact
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What this trial measures
- Proportion of Participants in Complete or Partial Remission (CR or PR) at Week 104.Week 104
. CR is defined as proteinuria of ≤ 0.3 g/day with a serum albumin ≥ 3.5 g/dL. PR is defined as a 50% or greater decrease in proteinuria compared to baseline and proteinuria \< 3.5 g/day glomerular filtration rate (eGFR) from baseline.