NephropathyBIOMANNCT02675686
Amniotic Biomarkers for the Prediction of Postpartum Renal Function.
An observational study of Nephropathy, run by University Hospital, Toulouse at 31 sites in France.
Trial summary
The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nephropathy
- How many people
- 358 participants
- Where
- 31 sitesFrance
- Study dates
- Dec 2010to Dec 2016
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population will be selected from 31 Multidisciplinary Prenatal Diagnosis Centers
Who may be able to join
- All fetuses with a bilateral abnormal renal development (structure modification of the parenchyma with or without urinary tract abnormalities associated)
- The following sonographic criteria are used:
- Fetal kidney size <2.5ep or <2 standard deviation (SD) defining renal hypoplasia or renal size> 97.5ep or> 2 SD defining nephromegaly
- And / or hyperechogenicity (more echogenic than the liver kidney)
- And / or cysts
- And / or abnormal cortico-medullary differentiation (decrease or lack thereof)
- And / or bilateral cortical thinning
- And / or the possibility of an initial unilateral renal disease in the case of a pathology on which kidney damage is usually to become bilateral during evolution
Who cannot join
- Foetuses with severe malformations that can change the amniotic or urine proteome: complex heart disease, digestive stenosis, fetal immobility.
- Fetus whose mother has chronic infectious diseases (HIV, hepatitis B and C) or acute infectious diseases such chorioamnionitis.
- Parental Refusal.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
France31 sites
Hopital Nord
Amiens
Chu D Angers
Angers, 49933
Hopital Saint Jacques
Besançon, 25030
Hopital Pellegrin
Bordeaux, 33076
Hopital Morvan
Brest, 29609
Hopital Femme-Mere-Enfant
Bron, 69500
Ch Rene Dubos Pontoise
Cergy-Pontoise, 95303
Hopital Antoine Beclere (Ap Hp)
Clamart, 92141
Chu Estaing
Clermont-Ferrand, 63003
Hopital Du Bocage
Dijon, 21000
Chu Grenoble
Grenoble, 38043
Hopital Jeanne de Flandre
Lille, 59037
Chu Dupuytren
Limoges, 87000
Hopital de La Timone (Ap Hm)
Marseille, 13385
Hopital Arnaud de Villeneuve
Montpellier, 34295
Hopital D'Enfants de Brabois
Nancy
Chu de Nantes
Nantes, 44093
Hopital Lenval
Nice, 06200
Centre Hospitalier CAREMEAU
Nîmes, 30029
Hopital Robert Debre
Paris, 75019
Hopital Armand Trousseau (Ap-Hp)
Paris, 75571
Hopital Necker Enfants Malades (Ap Hp)
Paris, 75743
CHRU De POITIERS LA MILETRIE
Poitiers, 86021
Hopital Maison Blanche
Reims, 51092
Hopital Sud
Rennes, 35203
Hopital Charles Nicole
Rouen, 76031
Hopital Nord
Saint-Priest-en-Jarez, 42277
Hopital de Hautepierre
Strasbourg, 67098
Maison de Sante Protestante de Bagatelle/Bordeaux
Talence, 33401
Chu Purpan
Toulouse, 31059
Hopital Bretonneau
Tours, 37000
About this study
Official title: Amniotic Fluid Biomarker Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study.
The discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution.
The objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies.
Read more
Both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included.
For this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study.
The potentially identified biomarkers will not change routine management of the pregnancies in the study.
- Conditions
- Nephropathy
- Medical subject headings
- Kidney Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function (according to Schwartz formula)
Renal function (according to Schwartz formula)
Measured: month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startDec 2010
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane. DECRAMER, MD; PHD, Principal investigator, Néphrologie pédiatrique - Hôpital des enfants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675686
- Sponsor's protocol ID
- 10 138 01
- Other IDs
- 2010-A01151-38
- Acronym
- BIOMAN
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2015
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Klein J, Buffin-Meyer B, Boizard F, Moussaoui N, Lescat O, Breuil B, Fedou C, Feuillet G, Casemayou A, Neau E, Hindryckx A, Decatte L, Levtchenko E, Raaijmakers A, Vayssiere C, Goua V, Lucas C, Perrotin F, Cloarec S, Benachi A, Manca-Pellissier MC, Delmas HL, Bessenay L, Le Vaillant C, Allain-Launay E, Gondry J, Boudailliez B, Simon E, Prieur F, Lavocat MP, Saliou AH, De Parscau L, Bidat L, Noel C, Floch C, Bourdat-Michel G, Favre R, Weingertner AS, Oury JF, Baudouin V, Bory JP, Pietrement C, Fiorenza M, Massardier J, Kessler S, Lounis N, Auriol FC, Marcorelles P, Collardeau-Frachon S, Zurbig P, Mischak H, Magalhaes P, Batut J, Blader P, Saulnier Blache JS, Bascands JL, Schaefer F, Decramer S, Schanstra JP; BIOMAN consortium. Amniotic fluid peptides predict postnatal kidney survival in developmental kidney disease. Kidney Int. 2021 Mar;99(3):737-749. doi: 10.1016/j.kint.2020.06.043. Epub 2020 Aug 1.
PubMed 32750455
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amniotic Fluid Biomarker Research for Prediction of Postnatal Renal Function in Fetus With a Bilateral Abnormal Renal Development: National, Multicenter, Prospective and Non-interventional Study.
- ClinicalTrials.gov ID
- NCT02675686
- Acronym / sponsor ID
- BIOMAN / 10 138 01
- Conditions
- Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Feb 2016 (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 discovery of antenatal bilateral renal anomaly poses an essential question: can we predict postnatal renal function? Ultrasound is insufficiently precise to predict postnatal renal function evolution.
The objective of this study is to estimate the specificity and sensitivity of amniotic fluid biomarkers to predict postnatal renal function in fetuses with bilateral developmental nephropathies.
Both fetuses with bilateral renal anomalies and control (healthy) fetuses will be included.
For this study amniotic fluid will only be collected according to routine clinical practice and only excess amniotic fluid sample will be used for the study.
The potentially identified biomarkers will not change routine management of the pregnancies in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population will be selected from 31 Multidisciplinary Prenatal Diagnosis Centers
Key inclusion criteria (8 listed)
- All fetuses with a bilateral abnormal renal development (structure modification of the parenchyma with or without urinary tract abnormalities associated)
- Fetal kidney size <2.5ep or <2 standard deviation (SD) defining renal hypoplasia or renal size> 97.5ep or> 2 SD defining nephromegaly
- And / or hyperechogenicity (more echogenic than the liver kidney)
- And / or cysts
- And / or abnormal cortico-medullary differentiation (decrease or lack thereof)
Key exclusion criteria (3 listed)
- Foetuses with severe malformations that can change the amniotic or urine proteome: complex heart disease, digestive stenosis, fetal immobility.
- Fetus whose mother has chronic infectious diseases (HIV, hepatitis B and C) or acute infectious diseases such chorioamnionitis.
- Parental Refusal.
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
Renal function (according to Schwartz formula)
Time frame: month 24
Renal function (according to Schwartz formula)
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 29 Nov 2024.
- Results publication: PubMed 32750455Klein J, Buffin-Meyer B, Boizard F, Moussaoui N, Lescat O, Breuil B, Fedou C, Feuillet G, Casemayou A, Neau E, Hindryckx A, Decatte L, Levtchenko E, Raaijmakers A, Vayssiere C, Goua V, Lucas C, Perrotin F, Cloarec S, Benachi A, Manca-Pellissier MC, Delmas HL, Bessenay L, Le Vaillant C, Allain-Launay E, Gondry J, Boudailliez B, Simon E, Prieur F, Lavocat MP, Saliou AH, De Parscau L, Bidat L, Noel C, Floch C, Bourdat-Michel G, Favre R, Weingertner AS, Oury JF, Baudouin V, Bory JP, Pietrement C, Fiorenza M, Massardier J, Kessler S, Lounis N, Auriol FC, Marcorelles P, Collardeau-Frachon S, Zurbig P, Mischak H, Magalhaes P, Batut J, Blader P, Saulnier Blache JS, Bascands JL, Schaefer F, Decramer S, Schanstra JP; BIOMAN consortium. Amniotic fluid peptides predict postnatal kidney survival in developmental kidney disease. Kidney Int. 2021 Mar;99(3):737-749. doi: 10.1016/j.kint.2020.06.043. Epub 2020 Aug 1.
- Individual participant dataSharing planned: Undecided
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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.
Stéphane. DECRAMER, MD; PHD principal investigator
Néphrologie pédiatrique - Hôpital des enfants
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephropathy, run by University Hospital, Toulouse at 31 sites 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 8 inclusion and 3 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites 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.
What does the primary outcome measure?
Renal function (according to Schwartz formula) (time frame: month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675686, which also lists 1 linked publication.
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 Nov 2024.