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

Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01185197

Enrollment

Registered

2010-08-19

Start date

2010-09-30

Completion date

2017-06-30

Last updated

2018-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrosis, Lipoid

Keywords

Minimal Change Nephrotic Syndrome, Corticosteroid, Mycophenolate, Remission, Safety

Brief 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).

Detailed description

This is a prospective, open-label, randomized study in which patients who present for the first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within 6 months of treatment cessation will be the main outcome parameters.

Interventions

DRUGMyfortic 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

DRUGPrednisolone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female 18 - 65 years of age * First histologic diagnosis of MCNS * Proteinuria \> 3.5 g/day * Patients who are willing to give written, informed consent

Exclusion criteria

* Presence of secondary causes of MCNS * History of glomerular disease including MCNS * eGFR \< 50 ml/min/1.73m2 * Renal histology showing pathologies other than MCNS * Female of child-bearing age who are unwilling to practice effective contraception * Patients simultaneously participating in another study or who have participated in another study within the last 30 days of entry into this study

Design outcomes

Primary

Measure	Time frame
Complete remission (24 hour urine protein < 0.3 g)	at 6 months

Secondary

Measure	Time frame
Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection	at 6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026