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

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04645589
• Other study ID #: CERL080ATW12
• Status: Recruiting
• Start date: March 16, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Keelung City
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Tao Yuan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reasons for study drug discontinuation	To describe the reasons for study drug discontinuation, including poor response, loss to follow-up, etc.	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of patients achieving inactive urinary sediment	The proportion of patients achieving inactive urinary sediment (no cellular casts)	month 6, month 12