NCT04645589

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-16
• Primary completion: 2025-06-13
• Completion: 2025-06-13
• First posted: 2020-11-27
• Last updated: 2025-12-09

Locations

6 sites across 1 country: Taiwan