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This prospective, randomized, controlled, multicenter clinical trial will evaluate Opportunity, Validity and Security of Steroids Plus Cyclosporin therapy for patients of Idiopathic Membranous Nephropathy.
Idiopathic membranous nephropathy is a main reason for nephropathy. Since it can get spontaneous remission, in KDIGO, it is recommend that initial therapy should be started only in patients with nephrotic syndrome and when at least the following condition is met:urinary protein excretion persistently exceeds 4g/d and remains at over 50% of the baseline value,and does not show progressive and antiproteinuric therapy during an observation period of at least 6 months. But many retrospective researches reported that using steroids and immunosuppressive agents were better than waiting for spontaneous remission. There were few prospective, randomized, controlled research on whether it is better that begin to use steroids and immunosuppressive agent early without waiting for 6 months. In our study,we evaluate the validity and security of steroids plus cyclosporin therapy in idiopathic membranous nephropathy. This will be a prospective, randomized, controlled, multicenter study. Patients in treatment group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. Patients in control group will waiting for spontaneous remission for 6 months,if there were no spontaneous remissions, patients in control group will receive oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. After followed-up for 6 months the curative and side effect of steroid plus cyclosporin therapy in the early stage of idiopathic membranous nephropathy will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: steroid & Cyclosporin | Experimental | oral methylprednisolone 0.4mg/kg/d and 3.5~5mg/kg/d cyclosporin for 6 months. |
|
| Group B: no steroid & Cyclosporin | No Intervention | no steroid and cyclosporin and waiting for spontaneous remission for 6 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| steroid & Cyclosporin | Drug | oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission of proteinuria (complete or partial) | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation). | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zongpei Jiang, MD&Ph D | Contact | 8620-38379727 | jx.home@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zongpei Jiang, MD &Ph.D | The Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology,Dongguan People's Hospital | Recruiting | Dongguan | Guangdong | 523059 | 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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| Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510260 | China |
|
| Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
|
| Department of Nephrology,Huizhou Municipal Central Hospital | Recruiting | Huizhou | Guangdong | 516001 | China |
|
| Department of Nephrology,1st Affiliated Hospital,Shenzhen University | Recruiting | Shenzhen | Guangdong | 518000 | China |
|
| Department of Nephrology,1st People's Hospital of Zhaoqing | Recruiting | Zhaoqing | Guangdong | 526020 | China |
|
| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| D011507 | Proteinuria |
| D012075 | Remission, Spontaneous |
| 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 |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013256 | Steroids |
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| 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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