Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

NCT01282073 | Completed Phase 3 Results DMC

• 1 other identifier: MMFPRIMER
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 9

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.

Conditions

Glomerulonephritis, Membranous

Keywords

Idiopathic membranous nephropathy; Mycophenolate mofetil; Proteinuria; Renal function

Outcome Measures

Primary Outcomes (2)

• 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

  at 48 week after treatment

• 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

  at 48 week after treatment

Secondary Outcomes (4)

• Estimated Glomerular Filtration Rate (eGFR)

  at 48 week after treatment

• Relapse

  For 48 weeks after treatment

• Proteinuria

  at 48 week after treatment

• Side Effects

  For 48 weeks after treatment

Study Arms (2)

Mycophenolate mofetil, low dose steroid

EXPERIMENTAL

Drug: Mycophenolate mofetil, low dose steroid

Cyclosporin, low dose steroid

ACTIVE COMPARATOR

Drug: Cyclosporin, low dose steroid

Interventions

Mycophenolate mofetil, low dose steroid DRUG

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

Also known as: Myconol, MMF

Mycophenolate mofetil, low dose steroid

Cyclosporin, low dose steroid DRUG

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

Also known as: Implanta soft capsule

Cyclosporin, low dose steroid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• hours urine protein or spot urine protein/creatinine ratio \> 5.0 g/day
• Serum albumin (g/dL) \< 3.0
• Selectivity index \> 0.2

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyungpook National University Hospital: lead
• Hanmi Pharmaceutical Company Limited: collaborator

Study Sites (9)

Dong-A University Medical Center

Busan, 602-715, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, South Korea

Location

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Daegu Fatima Hospital

Daegu, 701-600, South Korea

Location

Yeungnam University Medical Center

Daegu, 705-717, South Korea

Location

Seoul National University Hospital

Seoul, 110-799, South Korea

Location

Yonsei University Hospital

Seoul, 120-752, South Korea

Location

Boramae Medical Center

Seoul, 156-707, South Korea

Location

Ulsan University Hospital

Ulsan, 682-714, South Korea

Location

Related Publications (2)

• 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.

  PMID: 34778952 DERIVED

• 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.

  PMID: 29441742 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous; Proteinuria

Interventions

Mycophenolic Acid; Steroids; Cyclosporine

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Fused-Ring Compounds; Polycyclic Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Sun-Hee Park
• Organization: Kyungpook National University Hospital

sh-park@knu.ac.kr

+82532005547

Study Officials

• Sun-Hee Park, MD

  Kyungpook National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 24, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Locations

KR (9)