Clinical trial NCT02294344: 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
Overall status: TERMINATED
Phase: NA
Conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Keywords: double filtration plasmapheresis
ANCA-Associated Vasculitis
Lead sponsor: Nanjing University School of Medicine
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: the renal recovery rate
timeFrame: 3 months
Secondary outcomes:
measure: kidney survival
timeFrame: 12 months
Other outcomes:
measure: the antineutrophil cytoplasmic antibodies(ANCA) level at 12 month
timeFrame: 12 months
measure: relapse defined by birmingham vasculitis activity score(BVAS) increased more than 1.0 at 12 month
timeFrame: 12 months
measure: the change of BVAS
timeFrame: 12 months
measure: the change of Urine protein
timeFrame: 12 months
measure: the change of the count of urine sediment red blood cell
timeFrame: 12 months
measure: the change of the count of serum creatinine(SCr )
timeFrame: 12 months
measure: the change of estimated glomerular filtration rate(eGFR)
timeFrame: 12 months
measure: the vasculitis damage index(VDI) at 12 month
timeFrame: 12 months
Locations:
city: Nanjing
country: China
facility: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
state: Jiangsu
Study officials:
affiliation: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
name: Zhihong Liu, MD
role: STUDY_DIRECTOR
References: