Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

NCT ID: NCT00302510

Last Updated: 2010-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2003-08-31

Brief Summary

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The purpose of this study is to assess the efficacy and safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.

Detailed Description

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Lipoprotein glomerulopathy is characterized by nephritic syndrome glomerular protein thrombi and lipid abnormalities, particularly with an elevated level of plasma apoprotein E (apoE).There are no efficiency way to treat lipoprotein glomerulopathy. We firstly successfully treat 2 patients by protein A immunoadsorption with remarkable decreased urine protein and reduction of lipoprotein thrombi on repeated renal biopsy.

Conditions

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Treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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immunoadsorption

Group Type PLACEBO_COMPARATOR

immunoadsorption

Intervention Type PROCEDURE

immunoadsorption

Interventions

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immunoadsorption

immunoadsorption

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. A new diagnosis of lipoprotein glomerulopathy proved by histology and serology
2. Age 15\~60 years, sex free

Exclusion Criteria

1. Serum creatinine \> 500 umol/l
2. Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
3. Congenital or acquired immunodeficiency
4. Patients with severe infection or central nervous system symptoms
5. Immediately life-threatening organ manifestations (e.g. lung haemorrhage or massive gastro-intestinal bleeding, heart failure due to pericarditis or myocarditis, liver dysfunction measured on at least 2 separate occasion)
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Nanjing University School of Medicine

Principal Investigators

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Zhi-hong Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NJCT-0608

Identifier Type: -

Identifier Source: org_study_id

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