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

Novartis Pharmaceuticals69 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Lupus Nephritis

Interventions

MyforticDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 was defined as: 1. Kidney biopsy within 1 year, with histological diagnosis of LN (class III/IV/V) 2. 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. 5. 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. 6. 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: 1. Previous or planned kidney transplant. 2. Were 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 with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study.

Locations (6)

Novartis Investigative Site

Kaohsiung City, Taiwan

Novartis Investigative Site

Keelung, Taiwan

Novartis Investigative Site

Taichung, Taiwan

Novartis Investigative Site

Taipei, Taiwan

Outcomes

Primary Outcomes

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 was assessed via the adverse events (AEs), serious adverse events (SAEs) and deaths.

Time frame: 12 months

Secondary Outcomes

Reasons for study drug discontinuation

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

Time frame: 12 months

Proportion of patients with a complete response

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

Time frame: month 6, month 12

Proportion of patients with a partial response

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).

Time frame: 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)

Time frame: month 6, month 12

Proportion of patients achieving inactive urinary sediment

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

Data from ClinicalTrials.gov

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