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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nephrosis, Lipoid

Intervention / Treatment
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* Drug: Myfortic plus low-dose steroid
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Myfortic plus low-dose steroid<br>Not necessary | Drug: Myfortic plus low-dose steroid<br>* 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<br>* Other names: Mycophenolate sodium;|
| Active Comparator: Standard-dose steroid<br>Not necessary | Drug: Prednisolone<br>* 1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission (24 hour urine protein < 0.3 g) |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection |  | at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimal Change Nephrotic Syndrome, Corticosteroid, Mycophenolate, Remission, Safety