Back to resultsThe Clinical Efficacy of DFPP in Patients With AAGN
Primary Purpose
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DFPP&CTX
CTX
Sponsored by
About this trial
This is an interventional treatment trial for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis focused on measuring double filtration plasmapheresis, ANCA-Associated Vasculitis
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.
Sites / Locations
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DFPP&CTX
cyclophosphamide
Arm Description
double filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP&CTX)
cyclophosphamide(CTX) pulse therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
kidney survival
patient and kidney survival at 12 month
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02294344
Brief Title
The Clinical Efficacy of DFPP in Patients With AAGN
Official Title
A Prospective, Controlled Study of Double Filtration Plasmapheresis (DFPP) in Patients With Antineutrophil Cytoplasmic Autoantibody Associated Glomerulonephritis (AAGN)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
The recruitment of subject is very difficult.
Study Start Date
June 2014 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhi-Hong Liu, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Keywords
double filtration plasmapheresis, ANCA-Associated Vasculitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DFPP&CTX
Arm Type
Experimental
Arm Description
double filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP&CTX)
Arm Title
cyclophosphamide
Arm Type
Active Comparator
Arm Description
cyclophosphamide(CTX) pulse therapy
Intervention Type
Other
Intervention Name(s)
DFPP&CTX
Other Intervention Name(s)
Double Filtration Plasmapheresis +cyclophosphamide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
CTX
Other Intervention Name(s)
cyclophosphamide
Intervention Description
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.
Primary Outcome Measure Information:
Title
the renal recovery rate
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
kidney survival
Description
patient and kidney survival at 12 month
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
the antineutrophil cytoplasmic antibodies(ANCA) level at 12 month
Time Frame
12 months
Title
relapse defined by birmingham vasculitis activity score(BVAS) increased more than 1.0 at 12 month
Time Frame
12 months
Title
the change of BVAS
Time Frame
12 months
Title
the change of Urine protein
Time Frame
12 months
Title
the change of the count of urine sediment red blood cell
Time Frame
12 months
Title
the change of the count of serum creatinine(SCr )
Time Frame
12 months
Title
the change of estimated glomerular filtration rate(eGFR)
Time Frame
12 months
Title
the vasculitis damage index(VDI) at 12 month
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu, MD
Organizational Affiliation
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Clinical Efficacy of DFPP in Patients With AAGN
We'll reach out to this number within 24 hrs