Efficacy And Safety Of Zanubrutinib Vs Tacrolimus In Patients With Primary Membranous Nephropathy
Posted Date: Apr 22, 2024
- Investigator: Manish Anand
- Specialties:
- Type of Study: Drug
Primary Membranous Nephropathy affects about 10 in 1 million adults in North America. It is often characterized by high levels of protein in the urine, and about 60% of patients will progress to nephrotic-range proetinuria, leading to end stage kidney disease in about 50% within 15 years. Currently there are no approved therapies of primary membranous nephropathy (PMN). This study will compare the safety and efficacy of oral zanubrutinib to oral tacrolimus, a medication commonly given as an immunosuppressant following kidney transplant. This study will randomize patients to receive 160mg zanubrutinib once a day, twice a day or tacrolimus once a day for 64 weeks. Study visits will be weekly at the beginning, then decreased to every 12 or 16 weeks. Blood and urine samples will be drawn at every visit, and 24 hour urine collection is also required frequently.
Criteria:
Subjects Must Be 18 To 75 Years Of Age And Able To Provide Consent. They Must Have A Biopsy Proven Diagnosis Of Pmn With The Last 5 Years, And Have A Urinary Protein To Creatinine Ratio (Upcr) Of >3.5 Based On A 24 Hour Sample.. Patients With Uncontrolled Diabetes Or Hypertension Are Not Allowed. Med And Women Must Avoid Pregancy, Or Causing A Pregancy The Entire Period Of The Study. Other Criteria Apply.
Keywords:
Kidney, Proteinuria, Membranous
For More Information:
Heather Duncan
513-559-3362
heather.duncan@uc.edu