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

The University of Hong Kong (HKU)

Status and phase

Completed

Phase 4

Conditions

Nephrosis, Lipoid

Treatments

Drug: Prednisolone

Drug: Myfortic plus low-dose steroid

Study type

Interventional

Funder types

Other

Identifiers

NCT01185197

Novartis-ST-03

Details and patient eligibility

About

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).

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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