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

The University of Hong Kong20 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Nephrosis, Lipoid

Interventions

Myfortic plus low-dose steroidDRUG

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

PrednisoloneDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Queen Mary Hospital

Hong Kong, China

Outcomes

Primary Outcomes

Complete remission (24 hour urine protein < 0.3 g)

Time frame: at 6 months

Secondary Outcomes

Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection

Time frame: at 6 months

Data from ClinicalTrials.gov

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