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Clinical Trials List

Protocol NumberCERL080ATW12
NCT Number(ClinicalTrials.gov Identfier)NCT04645589
Active

2020-12-01 - 2025-12-31

Phase IV

Not yet recruiting1

Recruiting5

ICD-10E10.21

Type 1 diabetes mellitus with diabetic nephropathy

ICD-10E11.21

Type 2 diabetes mellitus with diabetic nephropathy

ICD-10N16

Renal tubulo-interstitial disorders in diseases classified elsewhere

ICD-9583.81

Nephritis and nephropathy, not specified as acute or chronic, in diseases classified elsewhere

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

  • Trial Applicant

    NOVARTIS (TAIWAN) CO., LTD.

  • Sponsor

    Novartis Pharmaceuticals

  • Trial scale

    Taiwan Multiple Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Shue-Fen Lo Division of Rheumatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭添財 Division of Rheumatology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIEH-YU SHEN Division of Rheumatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳詹永嬌 Division of Rheumatology
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator WEN-NAN HUANG Division of Rheumatology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 羅淑芬 Division of Rheumatology
Taipei Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Lupus Nephritis

Objectives

Primary objective: •To describe the safety profile of EC-MPS on LN patients. Secondary objectives: •To describe the reasons for study drug discontinuation during the 12-month period. •To investigate the efficacy of EC-MPS in LN patients, including renal function changes and the proportion of complete or partial responses during the 12-month period.

Test Drug

Myfortic 180 mg、360 mg Gastro-Resistant Tablets

Active Ingredient

mycophenolate sodium

Dosage Form

tablet

Dosage

180, 360

Endpoints

Primary Outcome Measures :

Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: month 6, month 12 ]
The proportion of patients achieving inactive urinary sediment (no cellular casts)

Inclution Criteria

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:

a. 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

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

The Estimated Number of Participants

  • Taiwan

    64 participants

  • Global

    0 participants

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