IgA NephropathyNCT01502579
An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data
An observational study of IgA Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The pathological variants of IgA nephropathy identified by the Oxford classification may be related to the clinical data at presentation and follow-up, including proteinuria and renal function. This study is aimed to identify the potential relationship between pathological variants and clinical data in IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- IgA Nephropathy
- How many people
- 603 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to Aug 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population from which the cohort will be selected is these who have received renal biopsy in Guangdong General Hospital
Who may be able to join
- biopsy-proven IgA nephropathy;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study of the Relationship Between Pathological Variants and Clinical Data at Presentation and Follow-up in IgA Nephropathy
The pathological variants of IgA nephropathy identified by the Oxford classification may be related to the clinical data at presentation and follow-up, including proteinuria and renal function. This study is aimed to identify the potential relationship between pathological variants and clinical data in IgA nephropathy.
- Conditions
- IgA Nephropathy
- Keywords
- IgA nephropathy
- Medical subject headings
- Glomerulonephritis, IGA
What is being measured
The primary outcome is the main question the study is designed to answer.
glomerular filtration rate decline or end-stage renal disease or doubling of serum creatinine
Measured: after the biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Shi, Guangdong Provincial People's Hospital
- Investigators
- Wei Shi, MD,PhD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502579
- Sponsor's protocol ID
- GGH201106
- Status last verified
- Aug 2013
- First submitted
- 29 Dec 2011
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Relationship Between Pathological Variants and Clinical Data at Presentation and Follow-up in IgA Nephropathy
- ClinicalTrials.gov ID
- NCT01502579
- Acronym / sponsor ID
- GGH201106
- Conditions
- IgA Nephropathy
- Keywords
- IgA nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Dec 2011 (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 pathological variants of IgA nephropathy identified by the Oxford classification may be related to the clinical data at presentation and follow-up, including proteinuria and renal function. This study is aimed to identify the potential relationship between pathological variants and clinical data in IgA nephropathy.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population from which the cohort will be selected is these who have received renal biopsy in Guangdong General Hospital
Key inclusion criteria (1 listed)
- biopsy-proven IgA nephropathy;
Key exclusion criteria (0 listed)
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
glomerular filtration rate decline or end-stage renal disease or doubling of serum creatinine
Time frame: after the biopsy
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 28 Aug 2013.
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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.
Wei Shi, MD,PhD principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IgA Nephropathy, run by Guangdong Provincial People's Hospital 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 1 inclusion and 0 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 28 Aug 2013. 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. 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?
glomerular filtration rate decline or end-stage renal disease or doubling of serum creatinine (time frame: after the biopsy). 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 28 Aug 2013.