Last Update: Jun 13, 2024
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
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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). This is an observational study. Patients will be treated and followed according to
routine medical practice in terms of visit frequency and type of assessment performed.
Only endpoint related data will be collected as part of the study. Patient demographic
information, disease characteristics, treatments and laboratory data will be collected
retrospectively.

Lupus Nephritis
Recruiting
64
Mar 16, 2021
Jul 31, 2025
All
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:

1. Aged ≥ 20 years and ≤ 75 years at screening.

2. Patients with written informed consent form.

3. Male or female diagnosed with SLE.

4. 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)

5. 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.

6. 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.

7. 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:

1. Previous or planned kidney transplant.

2. Currently receiving continuous dialysis or GFR < 30 mL/min/1.73 m2 within 3 months
prior to the start of study.

3. Patients with active serious digestive system disease, including infrequent cases of
gastrointestinal tract ulceration with hemorrhage or perforation.

4. Patients currently with life threatening conditions including malignancies, or
severe infection in recent 6 months prior to start of study

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