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Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study

NCT01185197 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-06-01

No results posted yet for this study

Summary

Study objective: To investigate the potential therapeutic efficacy of enteric-coated mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for minimal change nephrotic syndrome (MCNS).

Conditions

  • Nephrosis, Lipoid

Interventions

DRUG

Myfortic plus low-dose steroid

Prednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off

DRUG

Prednisolone

1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Sydney CW Tang, MD, PhD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • China

Study Locations

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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 NCT01185197 on ClinicalTrials.gov