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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: Myfortic

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.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Novartis Investigative Site
  • Keelung City, Taiwan, 20401
    • Novartis Investigative Site
  • Taichung, Taiwan, 40705
    • Novartis Investigative Site
  • Taipei, Taiwan, 10002
    • Novartis Investigative Site
  • Taipei, Taiwan, 105
    • Novartis Investigative Site
  • Tao Yuan, Taiwan, 333
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Myfortic; Oral administration	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.; Other Names: Mycophenolate sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reasons for study drug discontinuation	To describe the reasons for study drug discontinuation, including poor response, loss to follow-up, etc.	12 months
Proportion of patients with a complete response	Patients will be reported to have a complete response if their proteinuria is < 0.5 g/24 hours; or UPCR≤ 0.5.	month 6, month 12
Proportion of patients with a partial response	Patients will be 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).	month 6, month 12
Proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR)	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)	month 6, month 12
Proportion of patients achieving inactive urinary sediment	The proportion of patients achieving inactive urinary sediment (no cellular casts)	month 6, month 12

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lupus Nephritis; Myfortic; Mycophenolate sodium; LN
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Lupus Nephritis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antitubercular Agents; Antibiotics, Antitubercular; Mycophenolic Acid
• Other Study ID Numbers: CERL080ATW12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO