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A Phase III, Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients with Primary Membranous Nephropathy
To evaluate the effectiveness and safety of obinutuzumab compared to tacrolimus in patients with primary membranous nephropathy
Agree to participate in one of two treatment groups, attend scheduled study visits and have blood drawn for samples. will have visits approximately every 2 to 14 weeks during the first two years of the study, every 12-16 weeks in the third and fourth years of the study, and then every 26 weeks until you finish the study. Visits will usually last 1-3 hours, but visits that require an obinutuzumab infusion may last 6 hours. Your total time in the study will be a minimum of about 4 years, but could be up to about 9 years, depending on how the treatment affects your disease.
$100.00 per visit
Kim Hitz - at khitz1@pennstatehealth.psu.edu or 717-531-4924
All
18 year(s) or older
NCT04629248
STUDY00016316
Inclusion Criteria:
diagnosis of primary membranous nephropathyage 18-75
ability to comply with requried study procedures
stable blood pressure
Exclusion Criteria:
secondary cause of membranous nephropathyuncontrolled blood pressure
kidney transplant or dialysis
Type 1 or type 2 diabetes
Kidney & Urinary System