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| Name | Class |
|---|---|
| Hanmi Pharmaceutical Company Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate mofetil, low dose steroid | Experimental |
| |
| Cyclosporin, low dose steroid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 48 week after treatment |
| Relapse |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun-Hee Park, MD | Kyungpook National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A University Medical Center | Busan | 602-715 | South Korea | |||
| Inje University Haeundae Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34778952 | Derived | 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. | |
| 29441742 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mycophenolate Mofetil, Low Dose Steroid | Mycophenolate mofetil, low dose steroid: 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
|
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A relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission
| For 48 weeks after treatment |
| Proteinuria | The change of proteinuria from baseline to 48 week after treatment | at 48 week after treatment |
| Side Effects | Any undesired effects of interventional drugs | For 48 weeks after treatment |
| Busan |
| South Korea |
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
| Daegu Fatima Hospital | Daegu | 701-600 | South Korea |
| Yeungnam University Medical Center | Daegu | 705-717 | South Korea |
| Seoul National University Hospital | Seoul | 110-799 | South Korea |
| Yonsei University Hospital | Seoul | 120-752 | South Korea |
| Boramae Medical Center | Seoul | 156-707 | South Korea |
| Ulsan University Hospital | Ulsan | 682-714 | South Korea |
| FG001 | Cyclosporin, Low Dose Steroid | Cyclosporin, low dose steroid: 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 |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mycophenolate Mofetil, Low Dose Steroid | Mycophenolate mofetil, low dose steroid: 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 |
| BG001 | Cyclosporin, Low Dose Steroid | Cyclosporin, low dose steroid: 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | at 48 week after treatment |
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| ||||||||||||||||||||||||||||||
| Primary | 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 | Posted | Count of Participants | Participants | at 48 week after treatment |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | at 48 week after treatment | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Relapse | A relapse is return of proteinuria to approximately 3.5g/day in patients who had previously undergone a complete or partial remission | Not Posted | For 48 weeks after treatment | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Proteinuria | The change of proteinuria from baseline to 48 week after treatment | Not Posted | at 48 week after treatment | Participants | ||||||||||||||||||||||||||||||||||
| Secondary | Side Effects | Any undesired effects of interventional drugs | Not Posted | For 48 weeks after treatment | Participants |
48 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mycophenolate Mofetil, Low Dose Steroid | Mycophenolate mofetil, low dose steroid: 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 | 0 | 21 | 0 | 21 | 12 | 21 |
| EG001 | Cyclosporin, Low Dose Steroid | Cyclosporin, low dose steroid: 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 | 0 | 18 | 0 | 18 | 9 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Epigastric discomfort | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| New onset diabetes mellitus | Endocrine disorders | Systematic Assessment |
| ||
| Malignancy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun-Hee Park | Kyungpook National University Hospital | +82532005547 | sh-park@knu.ac.kr |
| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D013256 | Steroids |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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