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

Phase 4

Completed

• Conditions: Nephrosis, Lipoid
• Interventions: Drug: Myfortic plus low-dose steroid; Drug: Prednisolone

• Registration Number: NCT01185197
• Lead Sponsor: The University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2010-08-13
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Study Start: 2010-09
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myfortic plus low-dose steroid	Myfortic plus low-dose steroid	Not necessary
Standard-dose steroid	Prednisolone	Not necessary

Primary Outcome Measures

Name	Time	Method
Complete remission (24 hour urine protein < 0.3 g)	at 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Mary Hospital; 🇨🇳 Hong Kong, China