Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

Treatment Clinical Trial

Official title:

Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00302510
• Other study ID #: NJCT-0608
• Status: Completed
• Phase: N/A
• First received: March 13, 2006
• Last updated: May 25, 2010
• Start date: January 2000
• Est. completion date: August 2003

Study information

• Verified date: July 2008
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2003
• Est. primary completion date: March 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Treatment

Intervention

Procedure:
• immunoadsorption
immunoadsorption

Locations

Country	Name	City	State
China	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.		3 months	Yes
Secondary	To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.		3 months	Yes