NCT04645589Completed
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
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
This was 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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 69 (actual)
- First submitted
- 23 Nov 2020
- Start date
- 16 Mar 2021
- Primary completion date
- 13 Aug 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Lupus (SLE)
- NCT number
- NCT04645589
What you commit to
- Study type: Observational
- Participants enrolled: 69
- From 16 Mar 2021 to the primary completion date, 13 Aug 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or planned kidney transplant.
- Patients with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study.
Other illness
- Patients with active serious digestive system disease, including infrequent cases of gastrointestinal tract ulceration with hemorrhage or perforation.
Lab values
- Were receiving continuous dialysis or GFR \< 30 mL/min/1.73 m2 within 3 months prior to the start of study.
Who the study is looking for
- 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 was defined as:
- 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 receive any treatment before) could be included in this study.
- Women of childbearing potential must have used effective contraception before beginning EC MPS therapy, during therapy, and for six weeks after their last dose of EC MPS.
Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Keelung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.