The Clinical Efficacy of DFPP in Patients With AAGN

NCT02294344 | Terminated DMC

• 1 other identifier: NJCT1403
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Keywords

double filtration plasmapheresis; ANCA-Associated Vasculitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• kidney survival

  12 months

Other Outcomes (8)

• 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

Study Arms (2)

DFPP&CTX

EXPERIMENTAL

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

Other: DFPP&CTX

cyclophosphamide

ACTIVE COMPARATOR

cyclophosphamide(CTX) pulse therapy

Drug: CTX

Interventions

DFPP&CTX OTHER

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.

Also known as: Double Filtration Plasmapheresis +cyclophosphamide

DFPP&CTX

CTX DRUG

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.

Also known as: cyclophosphamide

cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhi-Hong Liu, M.D.: lead

Study Sites (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Zhihong Liu, MD

  Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: November 19, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: February 6, 2018

Record last verified: 2018-02

Locations

CN (1)