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

NCT ID: NCT01185197

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

Nephrosis, Lipoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Myfortic plus low-dose steroid

Not necessary

Group Type: EXPERIMENTAL

Myfortic plus low-dose steroid

Intervention Type: DRUG

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

Standard-dose steroid

Not necessary

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Prednisolone

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

Intervention Type: DRUG

Other Intervention Names

Mycophenolate sodium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sydney CW Tang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Queen Mary Hospital

Hong Kong, , China

Countries

China

References

Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.

Reference Type: DERIVED

PMID: 35230699 (View on PubMed)

Ma MKM, Yap DYH, Li CL, Mok MMY, Chan GCW, Kwan LPY, Lai KN, Tang SCW. Low-dose corticosteroid and mycophenolate for primary treatment of minimal change disease. QJM. 2020 Jun 1;113(6):399-403. doi: 10.1093/qjmed/hcz297.

Reference Type: DERIVED

PMID: 31769845 (View on PubMed)

Other Identifiers

Novartis-ST-03

Identifier Type: -

Identifier Source: org_study_id