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

NCT04645589 | Completed

• 1 other identifier: CERL080ATW12
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis; LN; Myfortic; Mycophenolate sodium

Outcome Measures

Primary Outcomes (1)

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

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

  12 months

Secondary Outcomes (5)

• Reasons for study drug discontinuation

  12 months

• Proportion of patients with a complete response

  month 6, month 12

• Proportion of patients with a partial response

  month 6, month 12

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

  month 6, month 12

• Proportion of patients achieving inactive urinary sediment

  month 6, month 12

Study Arms (1)

Myfortic

Oral administration

Drug: Myfortic

Interventions

Myfortic 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.

Also known as: Mycophenolate sodium

Myfortic

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of male and female patients diagnosed with LN between 20 and 75 years of age.

You may qualify if:

• 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:
• a. 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

Location

Novartis Investigative Site

Keelung, 20401, Taiwan

Location

Novartis Investigative Site

Taichung, 407219, Taiwan

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, 105, Taiwan

Location

Novartis Investigative Site

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: November 27, 2020
• Study Start: March 16, 2021
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)