Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

Nanjing University School of Medicine

Status: Completed

Conditions: Treatment

Treatments: Procedure: immunoadsorption

Study type: Interventional

Funder types: Other

Identifiers

NCT00302510

NJCT-0608

Details and patient eligibility

About

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

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 15 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group, including a placebo group

immunoadsorption

Placebo Comparator group

Treatment:

Procedure: immunoadsorption