Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis

Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis: a 12 Month, Single-arm, Observational Study in Taiwan Population

ClinicalTrials.gov Identifier: NCT04645589

Novartis Reference Number: CERL080ATW12

Last Update: Sep 09, 2022

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.

Study Description

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).

Condition

Lupus Nephritis

Phase

Not Given

Overall status

Recruiting

Start date

Mar 16, 2021

Completion date

Mar 31, 2024

Gender

All

Age(s)

20 Years - 75 Years (Adult, Older Adult)

Interventions

Drug

Myfortic

There is no treatment allocation. Patients administered Myfortic by prescription that have started before inclusion of the patient into the study will be enrolled.

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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