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

Primary Purpose

Nephrosis, Lipoid

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Myfortic plus low-dose steroid
Prednisolone
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrosis, Lipoid focused on measuring Minimal Change Nephrotic Syndrome, Corticosteroid, Mycophenolate, Remission, Safety

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Queen Mary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myfortic plus low-dose steroid

Standard-dose steroid

Arm Description

Not necessary

Not necessary

Outcomes

Primary Outcome Measures

Complete remission (24 hour urine protein < 0.3 g)

Secondary Outcome Measures

Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection

Full Information

First Posted
August 13, 2010
Last Updated
May 30, 2018
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01185197
Brief Title
Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study
Official Title
Myfortic® Combined With Low-dose Steroid in Minimal Change Nephrotic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrosis, Lipoid
Keywords
Minimal Change Nephrotic Syndrome, Corticosteroid, Mycophenolate, Remission, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myfortic plus low-dose steroid
Arm Type
Experimental
Arm Description
Not necessary
Arm Title
Standard-dose steroid
Arm Type
Active Comparator
Arm Description
Not necessary
Intervention Type
Drug
Intervention Name(s)
Myfortic plus low-dose steroid
Other Intervention Name(s)
Mycophenolate sodium
Intervention Description
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
Intervention Name(s)
Prednisolone
Intervention Description
1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician
Primary Outcome Measure Information:
Title
Complete remission (24 hour urine protein < 0.3 g)
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Occurrence of cushingoid facies, striae, acne, weight gain, GI disturbance, cytopenia, infection
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sydney CW Tang, MD, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35230699
Citation
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.
Results Reference
derived
PubMed Identifier
31769845
Citation
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.
Results Reference
derived

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

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