IGA GlomerulonephritisNCT00004305
Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis
An observational study of IGA Glomerulonephritis, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
OBJECTIVES: I. Determine whether allelic differences associated with the fourth component of complement, type-1 complement receptor expressed on erythrocytes, and Fc receptor FcgRIII contribute to the pathogenesis of IgA glomerulonephritis (IgA-N). II. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- IGA Glomerulonephritis
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to not given
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- IgA glomerulonephritis
Trial locations and contacts
1 site in 1 country.
About this study
OBJECTIVES: I. Determine whether allelic differences associated with the fourth component of complement, type-1 complement receptor expressed on erythrocytes, and Fc receptor FcgRIII contribute to the pathogenesis of IgA glomerulonephritis (IgA-N).
II. Compare genetic anomalies of these key components in immune complex processing and clearance between juvenile vs adult onset IgA-N vs normal controls.
Read the detailed description
PROTOCOL OUTLINE:
Participants undergo qualitative genetic analysis of complement-related proteins. Studies include: genomic re-arrangement of 4-gene unit, C4 DNA sequence and RNA expression, type-1 complement receptor DNA sequence, Fc-gamma receptor IIIA isoform analysis, classical and alternative complement activation pathway assays, plasma C4 and C4d protein levels, and immunoglobulin patterns in glomerular deposits.
- Conditions
- IGA Glomerulonephritis
- Keywords
- IgA glomerulonephritis, rare disease, renal and genitourinary disorders
- Medical subject headings
- Glomerulonephritis, IGA, Rare Diseases, Urogenital Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startJan 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IGA GlomerulonephritisStudies 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
- Enrolment
- 105 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University
- Investigators
- Lee A. Hebert, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004305
- Sponsor's protocol ID
- 199/11791
- Other IDs
- OSU-94H0338
- Status last verified
- Apr 2002
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis
- ClinicalTrials.gov ID
- NCT00004305
- Acronym / sponsor ID
- 199/11791
- Conditions
- IGA Glomerulonephritis
- Keywords
- IgA glomerulonephritis, rare disease, renal and genitourinary disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Ohio State University
- Study start
- Jan 1998
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Determine whether allelic differences associated with the fourth component of complement, type-1 complement receptor expressed on erythrocytes, and Fc receptor FcgRIII contribute to the pathogenesis of IgA glomerulonephritis (IgA-N).
II. Compare genetic anomalies of these key components in immune complex processing and clearance between juvenile vs adult onset IgA-N vs normal controls.
Detailed description
PROTOCOL OUTLINE:
Participants undergo qualitative genetic analysis of complement-related proteins. Studies include: genomic re-arrangement of 4-gene unit, C4 DNA sequence and RNA expression, type-1 complement receptor DNA sequence, Fc-gamma receptor IIIA isoform analysis, classical and alternative complement activation pathway assays, plasma C4 and C4d protein levels, and immunoglobulin patterns in glomerular deposits.
Study design
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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
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 24 Jun 2005.
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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.
Lee A. Hebert study chair
Ohio State University
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 Glomerulonephritis, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jun 2005. 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 United States. 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.
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 24 Jun 2005; AzTrials last refreshed its copy on 7 Nov 2026.