The Clinical Efficacy of DFPP in Patients With AAGN

Not Applicable

Terminated

• Conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Interventions: Other: DFPP&CTX; Drug: CTX

• Registration Number: NCT02294344
• Lead Sponsor: Zhi-Hong Liu, M.D.

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).

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-11-14
• Study First Posted: 2014-11-19
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-02
• Last Update Posted: 2018-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DFPP&CTX	DFPP&CTX	double filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP\&CTX)
cyclophosphamide	CTX	cyclophosphamide(CTX) pulse therapy

Primary Outcome Measures

Name	Time	Method
the renal recovery rate	3 months	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

Name	Time	Method
kidney survival	12 months	patient and kidney survival at 12 month

Trial Locations

Locations (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine; 🇨🇳 Nanjing, Jiangsu, China