Glomerulonephritis, MembranousNCT00199628
Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization
An observational study of Glomerulonephritis, Membranous and Neonatal Diseases and Abnormalities, run by University Hospital, Limoges at 1 site in France.
Trial summary
Problems of compatibility between a mother and her child are frequent. The most well-known case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which can induce severe anemia of the fetus. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Glomerulonephritis, Membranous, Neonatal Diseases and Abnormalities, Hemochromatosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Aug 2014
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: pregnant woman
Who may be able to join
- Mothers having a child suffering from:
- Neonatal membranous glomerulonephritis
- Unexplained neonatal tubular defect
- Unexplained thrombotic microangiopathy
- Neonatal hemochromatosis
Who cannot join
- Any cause explaining the child's disease
Trial locations and contacts
1 site in 1 country.
About this study
Problems of compatibility between a mother and her child are frequent. The most well-known case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which can induce severe anemia of the fetus.
The investigators recently proved that incompatibility between mother and child can concern an organ leading to a tissular alloimmunization. For example, neonatal membranous glomerulonephritis (a kidney disease) can result from this mechanism.
The purpose of this network is to detect and study neonatal diseases induced by tissular fetomaternal alloimmunization. The detection of these diseases will be performed by the mother's serum analysis.
- Keywords
- fetomaternal tissular alloimmunization, Mothers having a child suffering from:, neonatal membranous glomerulonephritis, unexplained neonatal tubular defect, unexplained thrombotic microangiopathy, neonatal hemochromatosis
- Medical subject headings
- Glomerulonephritis, Membranous, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Hemochromatosis, Neonatal hemochromatosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionAug 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glomerulonephritis, MembranousStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Guigonis, MD, Principal investigator, Department of Pediatrics, Limoges University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199628
- Sponsor's protocol ID
- I05001
- Status last verified
- Sep 2005
- First submitted
- 14 Sep 2005
- Last updated
- 15 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Network for Neonatal Diseases Induced by Tissular Fetomaternal Alloimmunization
- ClinicalTrials.gov ID
- NCT00199628
- Acronym / sponsor ID
- I05001
- Keywords
- fetomaternal tissular alloimmunization, Mothers having a child suffering from:, neonatal membranous glomerulonephritis, unexplained neonatal tubular defect, unexplained thrombotic microangiopathy, neonatal hemochromatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Sep 2005 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Sep 2005 (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.
Problems of compatibility between a mother and her child are frequent. The most well-known case can be illustrated by the fetomaternal blood group incompatibility (rhesus factor) which can induce severe anemia of the fetus.
The investigators recently proved that incompatibility between mother and child can concern an organ leading to a tissular alloimmunization. For example, neonatal membranous glomerulonephritis (a kidney disease) can result from this mechanism.
The purpose of this network is to detect and study neonatal diseases induced by tissular fetomaternal alloimmunization. The detection of these diseases will be performed by the mother's serum analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- pregnant woman
Key inclusion criteria (5 listed)
- Neonatal membranous glomerulonephritis
- Unexplained neonatal tubular defect
- Unexplained thrombotic microangiopathy
- Neonatal hemochromatosis
Key exclusion criteria (1 listed)
- Any cause explaining the child's disease
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 15 Jan 2019.
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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.
Vincent Guigonis, MD principal investigator
Department of Pediatrics, Limoges University 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 Glomerulonephritis, Membranous and Neonatal Diseases and Abnormalities, run by University Hospital, Limoges at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 15 Jan 2019. 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 France. 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 15 Jan 2019.