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Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults. There are few randomized clinical trials regarding the therapeutic effect of mycophenolate mofetil in patients with Idiopathic membranous nephropathy. This study aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission (complete or partial) of proteinuria in patients with idiopathic membranous nephropathy.
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. In recent year, IMN remains one of the most common glomerular diseases. Long-term remission and stable renal function can prevent idiopathic membranous nephropathy from progressing to end-stage renal disease. Cyclosporine and cyclophosphamide are recommended to be first-line treatment regimen. Corticosteroid is the basic combined drug in the treatment of idiopathic membranous nephropathy. Mycophenolate mofetil is a recently developed immunosuppressive agent with fewer renal toxicity than cyclosporin.Besides, high dose prednisone may be effective for patients in Asia according to literatures from Asia. In our study, patients with idiopathic membranous nephropathy would be treated with mycophenolate mofetil and high dose prednisone,whose outcome will be compared with cyclosporin and low dose prednisone. We aims to evaluate whether treatment with mycophenolate mofetil is non-inferior to cyclosporins in inducing long-term remission of proteinuria in patients with idiopathic membranous nephropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate mofetil | Experimental | Drug: Mycophenolate mofetil, high dose steroid Duration: 1 year |
|
| Cyclosporin | Active Comparator | Drug: Cyclosporin, low dose steroid Duration: 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil | Drug | steroid 1mg/kg/d and Mycophenolate mofetil 500mg bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission | Urinary protein excretion<0.3 g/d (uPCR<300 mg/g or <30 mg/mmol), confirmed by two values at least 1 week apart, accompanied by a normal serum albumin concentration, and a normal serum creatinine. | after treatment for 1 year. |
| Partial Remission | Urinary protein excretion <3.5 g/d (uPCR <3500 mg/g or <350 mg/mmol) and a 50% or greater reduction from peak values;confirmed by two values at least 1 week apart, accompanied by an improvement or normalization of the serum albumin concentration and stable serum creatinine. | after treatment for 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| estimated Glomerular Filtration Rate | time to a 50% reduction in baseline estimated Glomerular Filtration Rate (according to CKD-EPI) | after treatment for 1 year |
| serum creatinine | time to doubling of baseline creatinine |
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Inclusion Criteria:
1.Patients who provided informed consent
2.Patients who are diagnosed as membranous nephropathy by renal biopsy,and other secondary factors are excluded
3.18 years of age or older, male or female
4.24 hours urine protein or spot urine protein/creatinine ratio > 8.0 g/day at least for twice confirmed
5.The patients that satisfy more than three of following items are included even if proteinuria is less than 8 grams per day:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xinling Liang, M.D.,PH.D | Contact | 13808819770 | xinlingliang_ggh@163.com |
| Name | Affiliation | Role |
|---|---|---|
| xinling Liang, M.D.,PH.D | Nephrology Dept,Guangdong General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong General Hospital | Recruiting | Guangzhou | Guangdong | China |
| 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. |
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| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D003524 | Cyclosporins |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Drug: Mycophenolate mofetil, high dose steroid Drug: Cyclosporin, low dose steroid
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| Cyclosporins |
| Drug |
steroid 0.15mg/kg/d and Cyclosporin 3-5mg/kg/d |
|
| after treatment for 1 year |
| 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 |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |