Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

This study has been completed.

First Received: March 13, 2006 Last Updated: July 14, 2008 History of Changes

Sponsored by:	Nanjing University School of Medicine
Information provided by:	Nanjing University School of Medicine
ClinicalTrials.gov Identifier:	NCT00302510

Purpose

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

Condition	Intervention
Treatment	Procedure: immunoadsorption

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:

To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	20
Study Start Date:	January 2000
Study Completion Date:	August 2003
Primary Completion Date:	March 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental immunoadsorption	Procedure: immunoadsorption immunoadsorption

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.

Eligibility

Ages Eligible for Study:	15 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Serum creatinine > 500 umol/l
Severe viral infection(HBV, HCV, CMV) within 3 months of first randomization or known HIV infection
Congenital or acquired immunodeficiency
Patients with severe infection or central nervous system symptoms
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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302510

Locations

China, Jiangsu
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, China, 210002

Sponsors and Collaborators

Nanjing University School of Medicine

Investigators

Principal Investigator:

Zhi-hong Liu, M.D.

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

More Information

No publications provided

Responsible Party:	Nanjing University School of Medicine ( Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine )
Study ID Numbers:	NJCT-0608
Study First Received:	March 13, 2006
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00302510 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Nanjing University School of Medicine:

lipoprotein glomerulopathy
treatment
immunoadsorption
apolipoprotein E

ClinicalTrials.gov processed this record on September 02, 2009