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Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy

NCT02647255 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-10-08

No results posted yet for this study

Summary

Crescentic IgA nephropathy (CreIgAN) has a poor prognosis despite aggressive immunosuppressive therapy. The efficacy of plasma exchange (PE) in CreIgAN is not well defined. This study will evaluate the efficacy and safety of plasma exchange as adjunctive therapy for severe crescentic IgA nephropathy compared to pulse methylprednisolone on a background of oral prednisolone and cyclophosphamide in prevent kidney failure.

Conditions

  • Glomerulonephritis, IGA
  • Kidney Diseases
  • Acute Renal Insufficiency
  • Rapidly Progressive Glomerulonephritis

Interventions

PROCEDURE

Plasma Exchange (PE)

PE treatment\>7 within 3weeks; Volume exchanged: 60ml/kg/course; Replacement fluid: 5% Albumin or fresh frozen plasma; PE was performed by dialysis machine (IQ-21, Asahi Japan) and plasma separator (OP- 08W, Asahi Japan)

DRUG

Methylprednisolone pulse

methylprednisolone 7-15mg/kg/d 3 times, Qd. or Qod

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Hong Zhang, MD, PHD · Renal Division, Department of Medicine, Peking University First Hospital;Peking University Institute of Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-10-31
Completion
2020-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02647255 on ClinicalTrials.gov