All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
This is an open-label, prospective, single-arm, observational study in patients with Lupus nephritis (LN) who newly (i.e.,for the first time) received treatment of Enteric-coated Mycophenolate Sodium (EC-MPS).
Mar 16, 2021
Mar 31, 2024
20 Years - 75 Years (Adult, Older Adult)
There is no treatment allocation. Patients administered Myfortic by prescription that have started before inclusion of the patient into the study will be enrolled.
Aged ≥ 20 years and ≤ 75 years at screening.
Patients with written informed consent form.
Male or female diagnosed with SLE.
Confirmed diagnosis of LN by physician. Diagnosis of LN is defined as:
a. Kidney biopsy within 1 year, with histological diagnosis of LN (class III/IV/V)
Laboratory evidence of active nephritis: spot UPCR>0.5, and/or proteinuria > 0.5 g/24 hours, and/or greater than 3+ by dipstick, and/or cellular casts.
Patients with LN who received EC-MPS for the first time. The patients who switched from other treatment and treatment naive patients (did not received any treatment before) can be included in this study.
Women of childbearing potential must use effective contraception before beginning EC MPS therapy, during therapy, and for six weeks after their last dose of EC MPS.
Previous or planned kidney transplant.
Currently receiving continuous dialysis or GFR < 30 mL/min/1.73 m2 within 3 months prior to the start of study.
Patients with active serious digestive system disease, including infrequent cases of gastrointestinal tract ulceration with hemorrhage or perforation.
Patients currently with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study