NCT02294344

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Zhi-Hong Liu, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

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 After three months therapy, if the renal function was not recover, the patient would be withdrawn from the study.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

Timeline

• Start date: 2014-06-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2014-11-19
• Last updated: 2018-02-06

Locations

1 site across 1 country: China