The Clinical Efficacy of DFPP in Patients With AAGN

Study Overview
=================
Brief Summary
-----------------
The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).

Detailed Description
-----------------
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).

Official Title
-----------------
A Prospective, Controlled Study of Double Filtration Plasmapheresis (DFPP) in Patients With Antineutrophil Cytoplasmic Autoantibody Associated Glomerulonephritis (AAGN)

Conditions
-----------------
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Intervention / Treatment
-----------------
* Other: DFPP&CTX
* Drug: CTX


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of ANCA associated vasculitis(AAV), using criteria adapted from the disease definitions of the Chapel Hill consensus conference serum positive ANCA and the ANCA level ≥100 relative unit/ml with renal involvement and serum creatinine≥3 mg/dl written informed consent had been provided. Exclusion Criteria: other secondary vasculitis anti-glomerular basement membrane(GBM) positive severe infection; hepatitis B antigenemia, anti- hepatitis C virus immunodeficiency; or immunoglobulin G(IgG)<2g/l life threatening renal biopsy show globally sclerotic glomeruli>60% and normal glomeruli<10% need renal replacement therapy for more than 4w received large dose of methylprednisolone(MP),CTX,mycophenolate mofetil(MMF), plasmapheresis or intravenous immunoglobulin(IVIg) therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DFPP&CTX<br>double filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP&CTX) | Other: DFPP&CTX<br>* 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.<br>* Other names: Double Filtration Plasmapheresis +cyclophosphamide;|
| Active Comparator: cyclophosphamide<br>cyclophosphamide(CTX) pulse therapy | Drug: CTX<br>* 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.<br>* Other names: cyclophosphamide;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| kidney survival | patient and kidney survival at 12 month | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
double filtration plasmapheresis, ANCA-Associated Vasculitis