IgA NephropathyNCT01538433
A Survey of Factors Affecting an Early or Delayed Diagnosis of IgA Nephropathy
An observational study of IgA Nephropathy, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is a survey of factors which affect a pathologically defined early or delayed diagnosis of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford classification of IgA nephropathy. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- IgA Nephropathy
- How many people
- 603 participants
- Where
- 1 siteChina
- Study dates
- Feb 2012to Dec 2012
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The consecutive biopsy-proven IgAN patients in Guangdong General Hospital, Guangzhou,China
Who may be able to join
- biopsy-proven IgA Nephropathy patients in Guangdong General Hospital, Guangzhou,China
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Nephrology Department,Guangdong General Hospital
Guangzhou, Guangdong, 510080
About this study
Official title: A Survey of Factors Affecting an Early or Delayed Diagnosis of IgA Nephropathy: an Observational Study
This is a survey of factors which affect a pathologically defined early or delayed diagnosis of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford classification of IgA nephropathy. The factors to be surveyed include health examination including urine test, socioeconomic status of patients including education,etc.
- Conditions
- IgA Nephropathy
- Keywords
- diagnosis, IgA nephropathy
- Medical subject headings
- Glomerulonephritis, IGA, Disease
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 |
|---|---|---|
| biopsy-proven IgA nephropathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors potentially affecting an early or delayed diagnosis of IgA Nephropathy
Measured: Before the biopsy
Secondary outcomes (1)
Glomerular filtration rate(GFR) decline rate or reaching end-stage renal disease (ESRD) 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 posted24 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- Retrospective
- 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
- NCT01538433
- Sponsor's protocol ID
- GGH201107
- Status last verified
- Aug 2013
- First submitted
- 19 Feb 2012
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Survey of Factors Affecting an Early or Delayed Diagnosis of IgA Nephropathy: an Observational Study
- ClinicalTrials.gov ID
- NCT01538433
- Acronym / sponsor ID
- GGH201107
- Conditions
- IgA Nephropathy
- Keywords
- diagnosis, IgA nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 2012 (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.
This is a survey of factors which affect a pathologically defined early or delayed diagnosis of IgA nephropathy in Guangdong General Hospital, Guangzhou, China. An early or delayed diagnosis of IgA nephropathy is pathologically defined using the recently published Oxford classification of IgA nephropathy. The factors to be surveyed include health examination including urine test, socioeconomic status of patients including education,etc.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biopsy-proven IgA nephropathy | – | – |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The consecutive biopsy-proven IgAN patients in Guangdong General Hospital, Guangzhou,China
Key inclusion criteria (1 listed)
- biopsy-proven IgA Nephropathy patients in Guangdong General Hospital, Guangzhou,China
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
Factors potentially affecting an early or delayed diagnosis of IgA Nephropathy
Time frame: Before the biopsy
1 secondary outcome
Glomerular filtration rate(GFR) decline rate or reaching end-stage renal disease (ESRD) 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 19 Aug 2015.
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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 19 Aug 2015. 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?
Factors potentially affecting an early or delayed diagnosis of IgA Nephropathy (time frame: Before 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 19 Aug 2015.