ProteinuriaNCT01152060
Treatment for HBV-MN Patients in Chinese: An Open Parallel Controlled Trial
An observational study of Proteinuria and HBVe-antigen, run by Nanchang University.
Trial summary
Lamivudine treatment for HBV-DNA negative HBV-GN patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Proteinuria, HBVe-antigen
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Nov 2010
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: HBV-MN patients with heavy proteinuria in adults; HBsAg or HBeAg positive; HBV-DNA negative
Who may be able to join
- Adult HBV-GN patients with biopsy-proven MN, heavy protinuria, HBsAg or HBeAg positive, HBV-DNA negative
Who cannot join
- Primary MN patients, HBV-DNA positive
About this study
Official title: an Open Parallel Clinical Trial in HBV-GN Patients
Lamivudine treatment for HBV-DNA negative HBV-GN patients.
Read the detailed description
lamivudine and predinisone treatment for HBV-DNA negative HBV-GN patients.
- Conditions
- Proteinuria, HBVe-antigen
- Keywords
- remission of proteinuria, HBVe-antigen
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| prednisone | Not described | |
| prednisone and anti-virus | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ProteinuriaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchang University
- Sponsor type
- University, hospital or other
- Investigators
- Gaosi XU, MD & PhD, Study director, second affiliated hospital to nanchang university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152060
- Sponsor's protocol ID
- NCT00100504
- Status last verified
- May 2010
- First submitted
- 28 Jun 2010
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
PubMed 34778952Xu G, Duang Z, Wu X, Zou H, Fang X, Tu W. Treatment of hepatitis B virus-associated membranous nephritis patients in Chinese: an open parallel controlled trial. Clin Chem Lab Med. 2011 Jun;49(6):1077-8. doi: 10.1515/CCLM.2011.168. Epub 2011 Mar 17. No abstract available.
PubMed 21410411
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- an Open Parallel Clinical Trial in HBV-GN Patients
- ClinicalTrials.gov ID
- NCT01152060
- Acronym / sponsor ID
- NCT00100504
- Conditions
- Proteinuria, HBVe-antigen
- Keywords
- remission of proteinuria, HBVe-antigen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nanchang UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 29 Jun 2010 (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.
Lamivudine treatment for HBV-DNA negative HBV-GN patients.
Detailed description
lamivudine and predinisone treatment for HBV-DNA negative HBV-GN patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisone | – | – |
| prednisone and anti-virus | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- HBV-MN patients with heavy proteinuria in adults; HBsAg or HBeAg positive; HBV-DNA negative
Key inclusion criteria (1 listed)
- Adult HBV-GN patients with biopsy-proven MN, heavy protinuria, HBsAg or HBeAg positive, HBV-DNA negative
Key exclusion criteria (1 listed)
- Primary MN patients, HBV-DNA positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
- Derived from this study: PubMed 34778952von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.
- Derived from this study: PubMed 21410411Xu G, Duang Z, Wu X, Zou H, Fang X, Tu W. Treatment of hepatitis B virus-associated membranous nephritis patients in Chinese: an open parallel controlled trial. Clin Chem Lab Med. 2011 Jun;49(6):1077-8. doi: 10.1515/CCLM.2011.168. Epub 2011 Mar 17. No abstract available.
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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.
Gaosi XU, MD & PhD study director
second affiliated hospital to nanchang university
Questions about this trial
What is this clinical trial studying?
An observational study of Proteinuria and HBVe-antigen, run by Nanchang University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152060, which also lists 2 linked publications.
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 29 Jun 2010.