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The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis

NCT01015456 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-10-10

No results posted yet for this study

Summary

To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.

Conditions

Interventions

DRUG

mycophenolate sodium

per oral, twice daily, for 12 months

DRUG

cyclophosphamide

intravenous, monthly, for 6 months

Sponsors & Collaborators

  • Clinical Research Collaborative Network

    collaborator NETWORK

  • Health Intervention and Technology Assessment Program (HITAP)

    collaborator UNKNOWN

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Yingyos Avihingsanon, MD · Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Thailand

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01015456 on ClinicalTrials.gov