Status:
TERMINATED
The Clinical Efficacy of DFPP in Patients With AAGN
Lead Sponsor:
Zhi-Hong Liu, M.D.
Conditions:
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02294344
Start Date
June 1 2014
End Date
April 1 2017
Last Update
February 6 2018
Active Locations (1)
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1
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002