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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2025-06-13

Brief Summary

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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).

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Detailed Description

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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

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Lupus Nephritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Myfortic

Oral administration

Myfortic

Intervention Type DRUG

There is no treatment allocation. Patients administered Myfortic by prescription that have started before inclusion of the patient into the study will be enrolled.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Mycophenolate sodium

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No