NCT02949349

Brief Summary

This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2015

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

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.5 years

First QC Date

October 25, 2016

Last Update Submit

March 1, 2017

Conditions

Lupus Nephritis

Keywords

Systemic Lupus ErythematosusLupus NephritisMycophenolate MofetilAzathioprineMaintenance TherapyPrednisoloneSerum albuminSerum creatinineSpot urine protein/creatinine ratio

Outcome Measures

Primary Outcomes (3)

  • Change in serum albumin

    24 weeks treatment

  • Change in serum creatinine

    24 weeks treatment

  • Change in spot urine protein/creatinine ratio

    24 weeks treatment

Secondary Outcomes (8)

  • Change in serum albumin

    12 weeks treatment

  • Change in serum creatinine

    12 weeks treatment

  • Change in spot urine protein/creatinine ratio

    12 weeks treatment

  • Change in cholesterol

    24 weeks treatment

  • Change in triglyceride

    24 weeks treatment

  • +3 more secondary outcomes

Study Arms (3)

MMF 500mg

EXPERIMENTAL

Mycophenolate mofetil 500mg, PO BID

Drug: Mycophenolate mofetilDrug: Prednisolone

MMF 750mg

EXPERIMENTAL

Mycophenolate mofetil 750mg, PO BID

Drug: Mycophenolate mofetilDrug: Prednisolone

AZA

ACTIVE COMPARATOR

Azathioprine 1mg/kg, PO BID

Drug: AzathioprineDrug: Prednisolone

Interventions

Mycophenolate mofetilDRUG

Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.

Also known as: Mycocep Capsules
MMF 500mgMMF 750mg
AzathioprineDRUG

Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.

Also known as: Imuran Azathioprine Tablets
AZA
PrednisoloneDRUG

Daily dose not more than 10mg, orally, for 24 weeks.

AZAMMF 500mgMMF 750mg

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of lupus nephritis.
  • Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization.
  • Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization.

You may not qualify if:

  • Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis.
  • Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids.
  • Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks.
  • Previous kidney transplant or planned transplant.
  • Presence of life threatening complications such as cerebral lupus or severe infection.
  • Presence of liver dysfunction.
  • Presence of COPD or asthma requiring oral steroids.
  • Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus.
  • Presence of persistent hematuria or pyuria for causes other than lupus nephritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lupus NephritisLupus Erythematosus, Systemic

Interventions

Mycophenolic AcidAzathioprinePrednisolone

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsThionucleosidesSulfur CompoundsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ming-Han Chen, M.D., Ph.D.

    Taipei Veterans General Hospital, Taiwan, R.O.C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 31, 2016

Study Start

July 1, 2015

Primary Completion

December 30, 2016

Study Completion

January 25, 2017

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share