TreatmentNCT00302510
Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein Glomerulopathy
A study testing immunoadsorption in people with Treatment, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of immunoadsorption in the treatment of lipoprotein glomerulopathy. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment
- What is being tested?
- immunoadsorption
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2000to Aug 2003
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- A new diagnosis of lipoprotein glomerulopathy proved by histology and serology
- Age 15~60 years, sex free
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002
About this study
Official title: Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein
The purpose of this study is to assess the efficacy and safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.
Read the 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.
- Conditions
- Treatment
- Being tested
- immunoadsorption
- Keywords
- lipoprotein glomerulopathy, treatment, immunoadsorption, apolipoprotein E
- Medical subject headings
- Lipoprotein Glomerulopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunoadsorptionProcedure or surgery
immunoadsorption
| Study group | Role | What they receive |
|---|---|---|
| immunoadsorption | Placebo comparator | Not described Receives: Procedure: immunoadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.
Measured: 3 months
Secondary outcomes (1)
To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startJan 2000
- Primary completionMar 2002
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Zhi-hong Liu, M.D., Principal investigator, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302510
- Sponsor's protocol ID
- NJCT-0608
- Status last verified
- Jul 2008
- First submitted
- 13 Mar 2006
- Last updated
- 27 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Immunoadsorption for Patients With Lipoprotein
- ClinicalTrials.gov ID
- NCT00302510
- Acronym / sponsor ID
- NJCT-0608
- Conditions
- Treatment
- Keywords
- lipoprotein glomerulopathy, treatment, immunoadsorption, apolipoprotein E
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Mar 2002 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 14 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immunoadsorption | Placebo comparator | Procedure: immunoadsorption |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- A new diagnosis of lipoprotein glomerulopathy proved by histology and serology
- Age 15~60 years, sex free
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunoadsorptionimmunoadsorption | Procedure or surgery | immunoadsorption |
Primary outcome
To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy.
Time frame: 3 months
1 secondary outcome
To assess the safety of immunoadsorption in the treatment of lipoprotein glomerulopathy.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-hong Liu, M.D. principal investigator
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunoadsorption in people with Treatment, run by Nanjing University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of immunoadsorption in the treatment of lipoprotein glomerulopathy. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2010.