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The Clinical Efficacy of DFPP in Patients With AAGN

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02294344
Enrollment
14
Registered
2014-11-19
Start date
2014-06-30
Completion date
2017-04-30
Last updated
2018-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Keywords

double filtration plasmapheresis, ANCA-Associated Vasculitis

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).

Interventions

OTHERDFPP&CTX

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.

DRUGCTX

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 After three months therapy, if the renal function was not recover, the patient would be withdrawn from the study.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.

Sponsors

Zhi-Hong Liu, M.D.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
the renal recovery rate3 monthsthe 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

MeasureTime frameDescription
kidney survival12 monthspatient and kidney survival at 12 month

Other

MeasureTime frame
the change of BVAS12 months
the change of Urine protein12 months
the change of the count of urine sediment red blood cell12 months
the antineutrophil cytoplasmic antibodies(ANCA) level at 12 month12 months
the change of estimated glomerular filtration rate(eGFR)12 months
the vasculitis damage index(VDI) at 12 month12 months
the change of the count of serum creatinine(SCr )12 months
relapse defined by birmingham vasculitis activity score(BVAS) increased more than 1.0 at 12 month12 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026