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

Novartis

Status: Active, not recruiting

Conditions: Lupus Nephritis

Treatments: Drug: Myfortic

Study type: Observational

Funder types: Industry

Identifiers

NCT04645589

CERL080ATW12

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 1 patient group

Myfortic

Description:

Oral administration

Treatment:

Drug: Myfortic