The Clinical Efficacy of DFPP in Patients With AAGN

NCT ID: NCT02294344

Last Updated: 2018-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-04-30

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).

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DFPP&CTX

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

Group Type: EXPERIMENTAL

DFPP&CTX

Intervention Type: 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.

cyclophosphamide

cyclophosphamide(CTX) pulse therapy

Group Type: ACTIVE_COMPARATOR

CTX

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After three months therapy, if the renal function was not recover, the patient would be withdrawn from the study.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

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

Double Filtration Plasmapheresis +cyclophosphamide; cyclophosphamide

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhi-Hong Liu, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Zhi-Hong Liu, M.D.

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zhihong Liu, MD

Role: STUDY_DIRECTOR

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

Locations

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

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

NJCT1403

Identifier Type: -

Identifier Source: org_study_id