Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

This study has been completed.
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00302510
First received: March 13, 2006
Last updated: May 25, 2010
Last verified: July 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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
Placebo Comparator: immunoadsorption Procedure: immunoadsorption
immunoadsorption
Other Name: 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:

  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
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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: 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
Study First Received: March 13, 2006
Last Updated: May 25, 2010
Health Authority: China: 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 30, 2014