Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

Not Applicable

Completed

• Conditions: Treatment
• Interventions: Procedure: immunoadsorption

• Registration Number: NCT00302510
• Lead Sponsor: Nanjing University School of Medicine

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2002-03
• Study Completion: 2003-08
• Study First Submitted: 2006-03-13
• Study First Submitted QC: 2006-03-13
• Study First Posted: 2006-03-14
• Status Verified: 2008-07
• Last Update Submitted: 2010-05-25
• Last Update Posted: 2010-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immunoadsorption	immunoadsorption	-

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.	3 months

Secondary Outcome Measures

Name	Time	Method
To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.	3 months

Trial Locations

Locations (1)

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine; 🇨🇳 Nanjing, Jiangsu, China