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Completed

NCT Number: NCT00302510

Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

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

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nanjing, Jiangsu, 210002, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Immunoadsorption

Procedure

immunoadsorption

Primary outcomes

  1. To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.

    Time frame: 3 months

Secondary outcomes

  1. To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Official study title

Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein

Important dates

Study start
2000
Primary completion
2002
Study completion
2003
First posted
Mar 14, 2006
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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