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)

The clinical efficacy of double filtration plasmapheresis(DFPP) in patients with antineutrophil cytoplasmic autoantibody associated glomerulonephritis(AAGN).

Study Overview

• Status: Terminated
• Conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Intervention / Treatment: Other: DFPP&CTX; Drug: CTX

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DFPP&CTX; double filtration plasmapheresis(DFPP) combined with intravenous cyclophosphamide (IV-CTX) pulse therapy in addition(DFPP&CTX)	Other: DFPP&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.; Other Names: Double Filtration Plasmapheresis +cyclophosphamide
Active Comparator: cyclophosphamide; cyclophosphamide(CTX) pulse therapy	Drug: CTX; 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.; Other Names: cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
kidney survival	patient and kidney survival at 12 month	12 months

Other Outcome Measures

Outcome Measure	Time Frame
the antineutrophil cytoplasmic antibodies(ANCA) level at 12 month	12 months
relapse defined by birmingham vasculitis activity score(BVAS) increased more than 1.0 at 12 month	12 months
the change of BVAS	12 months
the change of Urine protein	12 months
the change of the count of urine sediment red blood cell	12 months
the change of the count of serum creatinine(SCr )	12 months
the change of estimated glomerular filtration rate(eGFR)	12 months
the vasculitis damage index(VDI) at 12 month	12 months

Collaborators and Investigators

• Sponsor: Zhi-Hong Liu, M.D.
• Investigators: Study Director: Zhihong Liu, MD, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: June 3, 2014
• First Submitted That Met QC Criteria: November 14, 2014
• First Posted (Estimate): November 19, 2014

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: ANCA-Associated Vasculitis; double filtration plasmapheresis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Autoimmune Diseases; Systemic Vasculitis; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide
• Other Study ID Numbers: NJCT1403