NCT00302510

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2002

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2006

Completed
Last Updated

May 27, 2010

Status Verified

July 1, 2008

Enrollment Period

2.2 years

First QC Date

March 13, 2006

Last Update Submit

May 25, 2010

Conditions

Treatment

Keywords

lipoprotein glomerulopathytreatmentimmunoadsorptionapolipoprotein E

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (1)

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

    3 months

Study Arms (1)

immunoadsorption

PLACEBO COMPARATOR
Procedure: immunoadsorption

Interventions

immunoadsorptionPROCEDURE

immunoadsorption

immunoadsorption

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • A new diagnosis of lipoprotein glomerulopathy proved by histology and serology
  • Age 15\~60 years, sex free

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Lipoprotein Glomerulopathy

Interventions

Plasmapheresis

Intervention Hierarchy (Ancestors)

Blood Component RemovalTherapeuticsSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Zhi-hong Liu, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2006

First Posted

March 14, 2006

Study Start

January 1, 2000

Primary Completion

March 1, 2002

Study Completion

August 1, 2003

Last Updated

May 27, 2010

Record last verified: 2008-07

Locations

CN(1)