NCT04645589

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2025

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

4.4 years

First QC Date

November 23, 2020

Last Update Submit

June 26, 2026

Conditions

Lupus Nephritis

Keywords

Lupus NephritisLNMyforticMycophenolate sodium

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (5)

  • Reasons for study drug discontinuation

    12 months

  • Proportion of patients with a complete response

    month 6, month 12

  • Proportion of patients with a partial response

    month 6, month 12

  • Proportion of patients achieving renal response in estimated glomerular filtration rate (eGFR)

    month 6, month 12

  • Proportion of patients achieving inactive urinary sediment

    month 6, month 12

Study Arms (1)

Myfortic

Oral administration

Drug: Myfortic

Interventions

MyforticDRUG

There is no treatment allocation. Patients administered Myfortic by prescription that had started before inclusion of the patient into the study were enrolled.

Also known as: Mycophenolate sodium
Myfortic

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of male and female patients diagnosed with LN between 20 and 75 years of age.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site

Kaohsiung City, 83301, Taiwan

Location

Novartis Investigative Site

Keelung, 20401, Taiwan

Location

Novartis Investigative Site

Taichung, 407219, Taiwan

Location

Novartis Investigative Site

Taipei, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, 105, Taiwan

Location

Novartis Investigative Site

Taoyuan, 33305, Taiwan

Location

Related Links

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

November 27, 2020

Study Start

March 16, 2021

Primary Completion

August 13, 2025

Study Completion

August 13, 2025

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(6)