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NCT Number: NCT04645589

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

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).

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Key information

Conditions

Lupus Nephritis Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Kaohsiung City, Taiwan

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About this study

This was an observational study. Patients were treated and followed according to routine medical practice in terms of visit frequency and type of assessment performed. Only endpoint related data were collected as part of the study. Patient demographic information, disease characteristics, treatments and laboratory data was collected retrospectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.

Exclusion criteria

  • Previous or planned kidney transplant.
  • Were 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 with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study.

Treatment and study plan

Myfortic

Drug

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

Other names: Mycophenolate sodium

Primary outcomes

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

    Time frame: 12 months

    The primary endpoint is the safety of EC-MPS in LN patients, which was assessed via the adverse events (AEs), serious adverse events (SAEs) and deaths.

Secondary outcomes

  1. Reasons for study drug discontinuation

    Time frame: 12 months

    To describe the reasons for study drug discontinuation, including poor response, loss to follow-up, etc.

  2. Proportion of patients with a complete response

    Time frame: month 6, month 12

    Patients were reported to have a complete response if their proteinuria is < 0.5 g/24 hours; or UPCR≤ 0.5.

  3. Proportion of patients with a partial response

    Time frame: month 6, month 12

    Patients were reported to have a partial response if they experience any one criteria as follows:

    • At least 50% decrease from baseline in proteinuria. Note: patients with a baseline proteinuria of >3.5 g/24 hours, must have a proteinuria < 3 g/24 hours;
    • Red blood cells per high power field (RBCs/HPF) ≤50% above baseline and no RBC casts;
    • At least 50% decrease in UPCR or to <1.0 (if 1.0 ≤ baseline ≤3.0) or to ≤3.0 (if baseline was >3.0).

  4. Proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR)

    Time frame: month 6, month 12

    The proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR).

    (eGFR within the normal range, or no less than 85% of baseline)

  5. Proportion of patients achieving inactive urinary sediment

    Time frame: month 6, month 12

    The proportion of patients achieving inactive urinary sediment (no cellular casts)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis: a 12 Month, Single-arm, Observational Study in Taiwan Population

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 27, 2020
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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