Clinical trial NCT01282073: Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy
Official title: A Randomized Controlled Multi-center Trial of Mycophenolate Mofetil for the Patient With High Risk Membranous Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glomerulonephritis, Membranous
Keywords: Idiopathic membranous nephropathy
Mycophenolate mofetil
Proteinuria
Renal function
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
Collaborators: name: Hanmi Pharmaceutical Company Limited
First posted: 2011-01-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of complete remission
timeFrame: at 48 week after treatment
measure: Percentage of partial remission
timeFrame: at 48 week after treatment
Secondary outcomes:
measure: estimated Glomerular filtration rate (eGFR)
timeFrame: at 48 week after treatment
measure: Relapse
timeFrame: For 48 weeks after treatment
measure: Proteinuria
timeFrame: at 48 week after treatment
measure: Side effects
timeFrame: For 48 weeks after treatment
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Hospital
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Sun-Hee Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.