Back to resultsMyfortic® 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
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
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
NCT ID
NCT01185197
First Posted
August 13, 2010
Last Updated
May 30, 2018
Sponsor
The University of Hong Kong
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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