Lupus NephritisNCT04645589
Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis
An observational study of Lupus Nephritis, run by Novartis Pharmaceuticals at 6 sites in Taiwan.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Myfortic
- Type of treatment
- Pill or oral medicine
- How many people
- 69 participants
- Where
- 6 sitesTaiwan
- Study dates
- 16 Mar 2021to 13 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of male and female patients diagnosed with LN between 20 and 75 years of age.
Who may be able to join
- 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 was 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 receive any treatment before) could be included in this study.
- 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.
Who cannot join
- Previous or planned kidney transplant.
- Were 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 with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Novartis Investigative Site
Kaohsiung City, 83301
Novartis Investigative Site
Keelung, 20401
Novartis Investigative Site
Taichung, 407219
Novartis Investigative Site
Taipei, 10002
Novartis Investigative Site
Taipei, 105
Novartis Investigative Site
Taoyuan, 33305
About this study
Official title: Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis: a 12 Month, Single-arm, Observational Study in Taiwan Population
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).
Read the detailed description
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.
- Conditions
- Lupus Nephritis
- Being tested
- Myfortic
- Keywords
- Lupus Nephritis, LN, Myfortic, Mycophenolate sodium
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyforticDrug
Also called Mycophenolate sodium
There is no treatment allocation. Patients administered Myfortic by prescription that had started before inclusion of the patient into the study were enrolled.
| Study group | Role | What they receive |
|---|---|---|
| Myfortic | Oral administration Receives: Drug: Myfortic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Reasons for study drug discontinuation
To describe the reasons for study drug discontinuation, including poor response, loss to follow-up, etc.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: month 6, month 12
Proportion of patients achieving inactive urinary sediment
The proportion of patients achieving inactive urinary sediment (no cellular casts)
Measured: month 6, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start16 Mar 2021
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645589
- Sponsor's protocol ID
- CERL080ATW12
- Status last verified
- Jun 2026
- First submitted
- 23 Nov 2020
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis: a 12 Month, Single-arm, Observational Study in Taiwan Population
- ClinicalTrials.gov ID
- NCT04645589
- Acronym / sponsor ID
- CERL080ATW12
- Conditions
- Lupus Nephritis
- Keywords
- Lupus Nephritis, LN, Myfortic, Mycophenolate sodium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myfortic | – | Drug: MyforticOral administration |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of male and female patients diagnosed with LN between 20 and 75 years of age.
Key inclusion criteria (8 listed)
- 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 was defined as:
- 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.
Key exclusion criteria (4 listed)
- Previous or planned kidney transplant.
- Were 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 with life threatening conditions including malignancies, or severe infection in recent 6 months prior to start of study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyforticAlso: Mycophenolate sodiumThere is no treatment allocation. Patients administered Myfortic by prescription that had started before inclusion of the patient into the study were enrolled. | Drug | Myfortic |
Primary outcome
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 was assessed via the adverse events (AEs), serious adverse events (SAEs) and deaths.
5 secondary outcomes
Reasons for study drug discontinuation
Time frame: 12 months
Proportion of patients with a complete response
Time frame: month 6, month 12
Proportion of patients with a partial response
Time frame: month 6, month 12
Proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR)
Time frame: month 6, month 12
Proportion of patients achieving inactive urinary sediment
Time frame: month 6, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Nephritis, run by Novartis Pharmaceuticals at 6 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety profile of Enteric-coated Mycophenolate Sodium (EC-MPS) on Lupus nephritis patients (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.