Not provided
Not provided
Not provided
Not provided
Not provided
The recruitment of subject is very difficult.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).
This is a single center, prospective, randomized,controlled study to compare the clinical efficacy of double filtration plasmapheresis (DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy versus IV-CTX pulse therapy in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFPP&CTX | Experimental | double filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP&CTX) |
|
| cyclophosphamide | Active Comparator | cyclophosphamide(CTX) pulse therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFPP&CTX | Other | First,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy. Then double volume of plasma was processed during each DFPP session every two day. A fraction plasma separator(Asahi Kasei Medical, surface area 2.0 m2,pore size 0.03 mm)and another fraction plasma separator (Asahi Kasei Medical, surface area 2.0 m2, pore size 0.01 mm)were used as first and second filter for plasma fractionation, respectively. 1.5 volume of plasma was processed, and 35~45g human albumin and blood plasma was supplemented during each session. The patients were treated with DFPP every two days for at least 3 times. After DFPP, 300-500ml blood plasma was supplemented. |
| Measure | Description | Time Frame |
|---|---|---|
| the renal recovery rate | the renal recovery rate at 3 mo defined by dialysis independence and the SCr <5mg/dl for the patients needed renal replacement therapy at the basement, or the SCr decreased more than 30% of the baseline and the urine sediment red blood cell less than 50*104/ml for the patients without renal replacement at the basement. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| kidney survival | patient and kidney survival at 12 month | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| the antineutrophil cytoplasmic antibodies(ANCA) level at 12 month | 12 months | |
| relapse defined by birmingham vasculitis activity score(BVAS) increased more than 1.0 at 12 month | 12 months | |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhihong Liu, MD | Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine | Nanjing | Jiangsu | 210002 | China |
Not provided
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| CTX | Drug | First,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy. After three months therapy, if the renal function was not recover, the patient would be withdrawn from the study. The other patients after CTX pulse therapy for 6 months and achieve remission to receive oral maintenance therapy with azathioprine (AZA). The dosage of AZA was 1.0-2.0mg/kg/d(more than 50mg/d) and adjusted by white cell count and liver enzyme. If white cell count <3×109/L or an increase in liver enzyme to more than twice the normal upper limit, the dosage of AZA should be reduced. If white cell count <3×109/L or liver enzyme increased repeatedly, the patient would be withdrawn from the study. |
|
|
| the change of BVAS |
| 12 months |
| the change of Urine protein | 12 months |
| the change of the count of urine sediment red blood cell | 12 months |
| the change of the count of serum creatinine(SCr ) | 12 months |
| the change of estimated glomerular filtration rate(eGFR) | 12 months |
| the vasculitis damage index(VDI) at 12 month | 12 months |
| D017445 |
| Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |