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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04645589

Collaborator

(none)

Enrollment

Locations

36.5

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lupus Nephritis	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 Design

Study Type:

Observational

Anticipated Enrollment :

64 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 16, 2021

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients [12 months]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 is 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 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novartis Investigative Site	Kaohsiung City	Taiwan	83301
2	Novartis Investigative Site	Taipei	Taiwan	10002
3	Novartis Investigative Site	Taipei	Taiwan	105
4	Novartis Investigative Site	Tao Yuan	Taiwan	333