CompletedNot Applicable

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

Taiwan72 participantsStarted 2021-03-16

Plain-language summary

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).

Who can participate

Age range20 Years – 75 Years

SexALL

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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:
✓. 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

What they're measuring

Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients

Timeframe: 12 months

Trial details

NCT IDNCT04645589

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-06-13

View on ClinicalTrials.gov More Lupus Nephritis trials