StudyFinder
Efficacy of Belimumab and Rituximab Compared to Rituximab Alone for the Treatment of Primary Membranous Nephropathy
Status: Recruiting
This trial is a two-part study (Part A and Part B) of adults with primary membranous nephropathy, ages 18-75 inclusive. Part A is an open-label, PK phase to compare belimumab exposure between participants who have “low” proteinuria (≥ 4 to < 8 g/day) and “high” proteinuria (≥ 8 g/day) at Visit -1. Part B is a prospective, randomized, phase II, double-blind, placebo-controlled, multicenter clinical trial in adults with primary MN. Part B will commence after the analysis of the PK data in Part A.
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
• 18 to 75 years old
• diagnosis of Membranous Nephropathy (MN) or Nephrotic Syndrome (study staff will review specific requirements)
• hypertension while on maximum medications i.e. systolic BP greater than 140mmHg or diastolic greater than 90mmHg
Exclusion Criteria:
• Rituximab use within the previous 12 months
• poorly controlled diabetes mellitus defined as hemoglobin A1c (HbA1c) 9.0% or greater
• women of child-bearing age who are pregnant, nursing, or unwilling to be sexually inactive or use FDA-approved contraception for the duration of the study
• additional medical and mental health exclusions apply, study staff will review
Interventions:
Drug: Belimumab, Drug: Placebo for Belimumab, Drug: Rituximab
Conditions:
Kidney, Prostate & Urinary
Keywords:
Clinics and Surgery Center (CSC), Membranous Nephropathy, Nephrotic Syndrome
Contact(s): Patrick Nachman - pnachman@umn.edu
Principal Investigator: Patrick Nachman
Phase: PHASE2
IRB Number: STUDY00006831
System ID: 26698
See this study on ClinicalTrials.gov