Therapeutic Effect of Immunoadsorption for Patients With... | NCT00302510

Studies
Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy

NCT00302510

Sponsor

Nanjing University School of Medicine

Status

Completed

Last Update Posted

May 27, 2010Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Treatment

Interventions

immunoadsorption

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Mar 2002Actual

Completion Date

Aug 2003Actual

First Submitted Date

Mar 13, 2006

First Submission Date that Met QC Criteria

Mar 13, 2006

First Posted Date

Mar 14, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2010

Last Update Posted Date

May 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
immunoadsorption	Placebo Comparator		Procedure: immunoadsorption

Interventions

Name	Type	Description	Arm Group Labels	Other Names
immunoadsorption	Procedure	immunoadsorption	immunoadsorption

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.		3 months

Secondary Outcomes

Measure	Description	Time Frame
To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhi-hong Liu, M.D.	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine		Nanjing	Jiangsu	210002	China

Condition Browse Module

MeSH Terms

ID	Term
C567089	Lipoprotein Glomerulopathy

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010956	Plasmapheresis

Ancestor Terms

ID	Term
D001781	Blood Component Removal
D013812	Therapeutics
D016060	Sorption Detoxification
D005112	Extracorporeal Circulation

Browse Leaves

Not provided

Browse Branches

Not provided