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

Nephrosis, Lipoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01185197
• Other study ID #: Novartis-ST-03
• Status: Completed
• Phase: Phase 4
• Start date: September 2010
• Est. completion date: June 2017

Study information

• Verified date: May 2018
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome

Intervention

Drug:
• Myfortic 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
• Prednisolone
1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete remission (24 hour urine protein < 0.3 g)		at 6 months
Secondary	Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection		at 6 months