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Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00302510
First Posted: March 14, 2006
Last Update Posted: May 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing University School of Medicine
  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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy. [ Time Frame: 3 months ]

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
Placebo Comparator: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00302510     History of Changes
Other Study ID Numbers: NJCT-0608
First Submitted: March 13, 2006
First Posted: March 14, 2006
Last Update Posted: May 27, 2010
Last Verified: July 2008

Keywords provided by Nanjing University School of Medicine:
lipoprotein glomerulopathy
treatment
immunoadsorption
apolipoprotein E