Clinical trial NCT04645589: Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis
Official title: Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis: a 12 Month, Single-arm, Observational Study in Taiwan Population
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lupus Nephritis
Keywords: Lupus Nephritis
LN
Myfortic
Mycophenolate sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2020-11-27
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients
timeFrame: 12 months
Secondary outcomes:
measure: Reasons for study drug discontinuation
timeFrame: 12 months
measure: Proportion of patients with a complete response
timeFrame: month 6, month 12
measure: Proportion of patients with a partial response
timeFrame: month 6, month 12
measure: Proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR)
timeFrame: month 6, month 12
measure: Proportion of patients achieving inactive urinary sediment
timeFrame: month 6, month 12
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Keelung City
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taoyuan
country: Taiwan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: