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Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy (MMFPRIMER)

Primary Purpose

Glomerulonephritis, Membranous

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mycophenolate mofetil, low dose steroid
Cyclosporin, low dose steroid
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glomerulonephritis, Membranous focused on measuring Idiopathic membranous nephropathy, Mycophenolate mofetil, Proteinuria, Renal function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with idiopathic membranous nephropathy
  2. The duration of disease is less than twelve months
  3. Patients with persistent proteinuria more than 8 grams per day
  4. Patients who provided informed consent

  5. The cases that satisfy more than three of following items even if proteinuria is less than 8 grams per day:

    • eGFR < 60 ml/min/1.73m2
    • Hypertension (BP above 140/90mmHg or BP above 120/80 in patients taking anti-hypertensive agents)
    • 24 hours urine protein or spot urine protein/creatinine ratio > 5.0 g/day
    • Serum albumin (g/dL) < 3.0
    • Selectivity index > 0.2

Exclusion Criteria:

  1. Severe digestive organ disease
  2. Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently.
  3. Clinical history of treatment with other immunosuppressive medication
  4. Probability of pregnancy, breast feeding woman
  5. Uncontrolled hypertension (more than 160/100mmHg)
  6. Uncontrolled systemic disease
  7. Drug addiction or alcoholics within 6 months
  8. eGFR is less than 30ml/min at screening
  9. Abnormal liver function test (more than 3 times above compared with normal value)
  10. Absolute neutrophil count <1,500/mm3 or leukocyte <2,500/mm3 or platelets <100,000/mm3
  11. Secondary membranous nephropathy
  12. Expected life expectancy is less than 1 year

Sites / Locations

  • Dong-A University Medical CenterRecruiting
  • Inje University Haeundae Paik HospitalRecruiting
  • Kyungpook National University HospitalRecruiting
  • Daegu Fatima HospitalRecruiting
  • Yeungnam University Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Yonsei University HospitalRecruiting
  • Boramae Medical CenterRecruiting
  • Ulsan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mycophenolate mofetil, low dose steroid

Cyclosporin, low dose steroid

Arm Description

Outcomes

Primary Outcome Measures

Percentage of complete remission
Complete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
Percentage of partial remission
Partial remission: Reduction in proteinuria to greater than 50 percent of initial values or absolute values of proteinuria between 200 mg and 3.5 g per day

Secondary Outcome Measures

estimated Glomerular filtration rate (eGFR)
The change of eGFR mesured by Modification of Diet in Renal Disease (MDRD) study equation from baseline to 1 year after treatment
Relapse
A relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission
Proteinuria
The change of proteinuria from baseline to 48 week after treatment
Side effects
Any undesired effects of interventional drugs

Full Information

First Posted
January 19, 2011
Last Updated
April 9, 2015
Sponsor
Kyungpook National University Hospital
Collaborators
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01282073
Brief Title
Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy
Acronym
MMFPRIMER
Official Title
A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
Collaborators
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cyclosporin decreases proteinuria and improve renal function in patients with idiopathic membranous nephropathy, but has a risk of side effects such as nephrotoxicity. The investigators plan to the study to evaluate whether mycophenolate mofetil (MMF) could be a reasonable alternative with fewer side effect.
Detailed Description
Idiopathic membranous nephropathy is most common cause of glomerulonephritis in adults. Persistent high grade proteinuria or progressively decrease of renal function is a risk factor for end stage renal disease in idiopathic membranous nephropathy. It has been reported that cyclosporin in patients with idiopathic membranous nephropathy decreases proteinuria and improve renal function. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer side effect than cyclosporin. In this study patients with high risk group of progressive idiopathic membranous nephropathy will be treated with mycophenolate mofetil and low dose prednisone. The outcome will be compared to controls treated with cyclosporin and low dose prednisone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, Membranous
Keywords
Idiopathic membranous nephropathy, Mycophenolate mofetil, Proteinuria, Renal function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mycophenolate mofetil, low dose steroid
Arm Type
Experimental
Arm Title
Cyclosporin, low dose steroid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Mycophenolate mofetil, low dose steroid
Other Intervention Name(s)
Myconol, MMF
Intervention Description
Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 ~ 1000 mg bid per day (more than 50kg) Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day Duration: 48 weeks
Intervention Type
Drug
Intervention Name(s)
Cyclosporin, low dose steroid
Other Intervention Name(s)
Implanta soft capsule
Intervention Description
Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml) Steroid: same dosage with active comparator goup Duration: 48 weeks
Primary Outcome Measure Information:
Title
Percentage of complete remission
Description
Complete remission: Reduction in proteinuria to 200 mg per day with stable serum albumin with more than 3.5 g/dL
Time Frame
at 48 week after treatment
Title
Percentage of partial remission
Description
Partial remission: Reduction in proteinuria to greater than 50 percent of initial values or absolute values of proteinuria between 200 mg and 3.5 g per day
Time Frame
at 48 week after treatment
Secondary Outcome Measure Information:
Title
estimated Glomerular filtration rate (eGFR)
Description
The change of eGFR mesured by Modification of Diet in Renal Disease (MDRD) study equation from baseline to 1 year after treatment
Time Frame
at 48 week after treatment
Title
Relapse
Description
A relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission
Time Frame
For 48 weeks after treatment
Title
Proteinuria
Description
The change of proteinuria from baseline to 48 week after treatment
Time Frame
at 48 week after treatment
Title
Side effects
Description
Any undesired effects of interventional drugs
Time Frame
For 48 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with idiopathic membranous nephropathy The duration of disease is less than twelve months Patients with persistent proteinuria more than 8 grams per day Patients who provided informed consent The cases that satisfy more than three of following items even if proteinuria is less than 8 grams per day: eGFR < 60 ml/min/1.73m2 Hypertension (BP above 140/90mmHg or BP above 120/80 in patients taking anti-hypertensive agents) 24 hours urine protein or spot urine protein/creatinine ratio > 5.0 g/day Serum albumin (g/dL) < 3.0 Selectivity index > 0.2 Exclusion Criteria: Severe digestive organ disease Allergy history to clinical trial medication and acute or chronic allergy for 4 weeks recently. Clinical history of treatment with other immunosuppressive medication Probability of pregnancy, breast feeding woman Uncontrolled hypertension (more than 160/100mmHg) Uncontrolled systemic disease Drug addiction or alcoholics within 6 months eGFR is less than 30ml/min at screening Abnormal liver function test (more than 3 times above compared with normal value) Absolute neutrophil count <1,500/mm3 or leukocyte <2,500/mm3 or platelets <100,000/mm3 Secondary membranous nephropathy Expected life expectancy is less than 1 year
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee-Yeon Jung, MD
Phone
+82-10-2536-4106
Email
83mayring@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sun-Hee Park, MD
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong-A University Medical Center
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won-Suk An, MD
Email
anws@dau.ac.kr
First Name & Middle Initial & Last Name & Degree
Won-Suk An, MD
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyu-Bok Jin, MD
Email
mdjin922@gmail.com
First Name & Middle Initial & Last Name & Degree
Yang-Wook Kim, MD
First Name & Middle Initial & Last Name & Degree
Kyu-Bok Jin, MD
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee-Yeon Jung, MD
Phone
+82-10-2536-4106
Email
83mayring@hanmail.net
First Name & Middle Initial & Last Name & Degree
Yong-Lim Kim, MD
First Name & Middle Initial & Last Name & Degree
Sun-Hee Park, MD
First Name & Middle Initial & Last Name & Degree
Chan-Duck Kim, MD
First Name & Middle Initial & Last Name & Degree
Jang-Hee Cho, MD
First Name & Middle Initial & Last Name & Degree
Ji-Young Choi, MD
Facility Name
Daegu Fatima Hospital
City
Daegu
ZIP/Postal Code
701-600
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duk-Hyun Lee, MD
Phone
+82-53-940-7221
Email
dhlee@fatima.or.kr
First Name & Middle Initial & Last Name & Degree
Sung-Ho Kim, MD
First Name & Middle Initial & Last Name & Degree
Duk-Hyun Lee, MD
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyu Hyang Cho, MD
Email
drtoto@hanmail.net
First Name & Middle Initial & Last Name & Degree
Kyu Hyang Cho, MD
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yon Su Kim, MD
Email
yonsukim@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Suhnggwoon Kim, MD
First Name & Middle Initial & Last Name & Degree
Dong Ki Kim, MD
First Name & Middle Initial & Last Name & Degree
Su Mi Lee, MD
First Name & Middle Initial & Last Name & Degree
Yon Su Kim, MD
Facility Name
Yonsei University Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Hyun Yoo, MD
Email
YOOSY0316@yuhs.ac
First Name & Middle Initial & Last Name & Degree
Shin-Wook Kang, MD
First Name & Middle Initial & Last Name & Degree
Seung Hyeok Han, MD
First Name & Middle Initial & Last Name & Degree
Tae-Hyun Yoo, MD
Facility Name
Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Pyo Lee, MD
Email
kjwa1@medimail.co.kr
First Name & Middle Initial & Last Name & Degree
Chun Soo Lim, MD
First Name & Middle Initial & Last Name & Degree
Yun Kyu Oh, MD
First Name & Middle Initial & Last Name & Degree
Jung Pyo Lee, MD
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
682-714
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun-Chul Chung, MD
Email
hcjungmd@uuh.ulsan.kr
First Name & Middle Initial & Last Name & Degree
Jong-Soo Lee, MD
First Name & Middle Initial & Last Name & Degree
Hyun-Chul Chung, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34778952
Citation
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
Results Reference
derived
PubMed Identifier
29441742
Citation
Choi JY, Kim DK, Kim YW, Yoo TH, Lee JP, Chung HC, Cho KH, An WS, Lee DH, Jung HY, Cho JH, Kim CD, Kim YL, Park SH. The Effect of Mycophenolate Mofetil versus Cyclosporine as Combination Therapy with Low Dose Corticosteroids in High-risk Patients with Idiopathic Membranous Nephropathy: a Multicenter Randomized Trial. J Korean Med Sci. 2018 Feb 26;33(9):e74. doi: 10.3346/jkms.2018.33.e74.
Results Reference
derived

Learn more about this trial

Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

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