Kidney DiseasesPAPER FACENCT06912490
Proteomic Analysis of Amniotic Fluid to Predict Postnatal Renal Function in Fetuses With Renal and Urinary Tract Malformations
A study testing Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS) in people with Kidney Diseases, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The aim of this project is to validate a previously established amniotic fluid 98 peptide signature predictive of post-natal outcome in fetuses with congenital anomalies of the kidney and the urinary tract (CAKUT) in a "real" clinical context. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Kidney Diseases
- What is being tested?
- Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2025to 20 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- All fetuses with bilateral renal development anomalies with structural changes in the parenchyma, with or without associated urinary tract anomalies;
- Signed informed consent of the mother
- Non-opposition of the father.
Who cannot join
- Unilateral abnormality of renal development
- Any pregnancy for which amniocentesis may represent a risk for the fetus or the mother
- Twin pregnancies
- Pregnant woman protected by law (guardianship, curatorship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Children Hospital
Toulouse, 31059
Thomas SIMON, +33 05 34 55 84 58, simon.t@chu-toulouse.fr
Thomas SIMON
About this study
The aim of this project is to validate a previously established amniotic fluid 98 peptide signature predictive of post-natal outcome in fetuses with congenital anomalies of the kidney and the urinary tract (CAKUT) in a "real" clinical context. It includes the feasibility of collecting, transporting and analyzing the amniotic fluid peptidome from clinical centers all over France and of providing the result in a clinically accepted time-frame. Therefore, this multicenter study will not only allow to determine the added value of such new prenatal test but also to ensure the feasibility of its introduction in the management of CAKUT pregnancies.
Read the detailed description
CAKUT represent 20-30% of all inborn malformations. Whereas prognosis is generally favorable in unilateral disease, bilateral CAKUT are the predominant causes of chronic kidney disease (CKD) in childhood and account for ~50% of pediatric and young adult end stage renal disease (ESRD) cases. Current ultrasound- or amniotic fluid biochemistry-based prenatal clinical advice to parents expecting a child with bilateral CAKUT is far from accurate. This prognostic uncertainty of disease progression has particularly serious implications for parents confronted with the decision of continuation or elective termination of pregnancy. Such uncertainty has led to documented situations where half of the cases of severe bilateral CAKUT for whom termination of pregnancy was considered but not performed had normal postnatal renal function. In the case parents decide to continue the pregnancy, knowledge of the precise outcome would allow anticipating dialysis, transplantation or palliative care. 98 peptide signature have been identified in amniotic liquid that predicted with high sensitivity and specificity postnatal kidney function in fetuses with CAKUT (Klein, Buffin-Meyer et al., Kidney Int 2021).
The aim of the current project is to validate this signature in an independent multicenter French study and determine added value and feasibility of its introduction in the routine management of CAKUT pregnancies.
After the discovery of a CAKUT pregnancy in an associated French center and approval and informed consent of the parents, part of the amniotic fluid (~ 1 mL) that is routinely collected for chromosomal anomalies is transferred to the research laboratory Inserm U1297 in Toulouse. The peptide content of the amniotic fluid is analyzed allowing the evaluation of the abundance of the 98 peptides of the signature. It will result in a risk score for developing severe kidney failure before the age of 2 years, postnatally. This score will be communicated by the clinicians from Toulouse responsible for the project to the clinicians of the center requesting the analysis.
- Conditions
- Kidney Diseases
- Being tested
- Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS)
- Keywords
- Antenatal, fetal bilateral nephropathies, renal function, prognosis, proteomic analysis, renal ultrasound
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS)Other
This intervention consists of analyzing the amniotic fluid proteome using capillary electrophoresis coupled with mass spectrometry (CE-MS). The goal is to evaluate a predefined 98-peptide signature that predicts postnatal kidney function in fetuses with bilateral congenital anomalies of the kidney and urinary tract. Unlike standard prenatal assessments based on ultrasound and fetal biochemistry, this method provides a molecular-based prognostic tool to improve decision-making regarding pregnancy management and neonatal care
| Study group | Role | What they receive |
|---|---|---|
| Proteomic-Based Prediction of Postnatal Kidney Function in Fetuses with Bilateral CAKUT | Experimental | Not described Receives: Other: Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the test in the evaluation of renal survival (need for dialysis) and patient survival at 2 years of life.
Renal survival is defined as the absence of end-stage renal disease (ESRD) requiring dialysis by 2 years of age. Patient survival is defined as the child being alive at 2 years. Renal function is assessed through clinical follow-up, including serum creatinine measurements and estimated glomerular filtration rate (eGFR) using the Schwartz formula. Dialysis initiation is determined based on standard clinical criteria for ESRD. Survival status is confirmed through medical records and follow-up visits. This outcome aims to validate the predictive value of the 98-peptide amniotic fluid signature for postnatal kidney function in CAKUT fetuses.
Measured: 2 years of age
Secondary outcomes (2)
Sensitivity and specificity of the test in the evaluation of postnatal renal function estimated by the Schwartz formula and his serum creatinine
Schwartz formula which is based on the patient's height (T, in cm) and his serum creatinine (Creat, in µmol/L) (T*36.5/Creat)
Measured: At months 1, 6, 12, and 24 postnatally
Severity score result rendering time
measure of the delay to give the result to the investigator site
Measured: up to 2 weeks after sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start18 Jul 2025
- Primary completion20 Dec 2029 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912490
- Sponsor's protocol ID
- RC31/24/0291
- Other IDs
- ID-RCB : 2024-A01612-45
- Acronym
- PAPER FACE
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomic Analysis of Amniotic Fluid to Predict Postnatal Renal Function in Fetuses With Renal and Urinary Tract Malformations
- ClinicalTrials.gov ID
- NCT06912490
- Acronym / sponsor ID
- PAPER FACE / RC31/24/0291
- Conditions
- Kidney Diseases
- Keywords
- Antenatal, fetal bilateral nephropathies, renal function, prognosis, proteomic analysis, renal ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 20 Dec 2029 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 4 Apr 2025 (actual)
- 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 aim of this project is to validate a previously established amniotic fluid 98 peptide signature predictive of post-natal outcome in fetuses with congenital anomalies of the kidney and the urinary tract (CAKUT) in a "real" clinical context. It includes the feasibility of collecting, transporting and analyzing the amniotic fluid peptidome from clinical centers all over France and of providing the result in a clinically accepted time-frame. Therefore, this multicenter study will not only allow to determine the added value of such new prenatal test but also to ensure the feasibility of its introduction in the management of CAKUT pregnancies.
Detailed description
CAKUT represent 20-30% of all inborn malformations. Whereas prognosis is generally favorable in unilateral disease, bilateral CAKUT are the predominant causes of chronic kidney disease (CKD) in childhood and account for ~50% of pediatric and young adult end stage renal disease (ESRD) cases. Current ultrasound- or amniotic fluid biochemistry-based prenatal clinical advice to parents expecting a child with bilateral CAKUT is far from accurate. This prognostic uncertainty of disease progression has particularly serious implications for parents confronted with the decision of continuation or elective termination of pregnancy. Such uncertainty has led to documented situations where half of the cases of severe bilateral CAKUT for whom termination of pregnancy was considered but not performed had normal postnatal renal function. In the case parents decide to continue the pregnancy, knowledge of the precise outcome would allow anticipating dialysis, transplantation or palliative care. 98 peptide signature have been identified in amniotic liquid that predicted with high sensitivity and specificity postnatal kidney function in fetuses with CAKUT (Klein, Buffin-Meyer et al., Kidney Int 2021).
The aim of the current project is to validate this signature in an independent multicenter French study and determine added value and feasibility of its introduction in the routine management of CAKUT pregnancies.
After the discovery of a CAKUT pregnancy in an associated French center and approval and informed consent of the parents, part of the amniotic fluid (~ 1 mL) that is routinely collected for chromosomal anomalies is transferred to the research laboratory Inserm U1297 in Toulouse. The peptide content of the amniotic fluid is analyzed allowing the evaluation of the abundance of the 98 peptides of the signature. It will result in a risk score for developing severe kidney failure before the age of 2 years, postnatally. This score will be communicated by the clinicians from Toulouse responsible for the project to the clinicians of the center requesting the analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proteomic-Based Prediction of Postnatal Kidney Function in Fetuses with Bilateral CAKUT | Experimental | Other: Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All fetuses with bilateral renal development anomalies with structural changes in the parenchyma, with or without associated urinary tract anomalies;
- Signed informed consent of the mother
- Non-opposition of the father.
Key exclusion criteria (4 listed)
- Unilateral abnormality of renal development
- Any pregnancy for which amniocentesis may represent a risk for the fetus or the mother
- Twin pregnancies
- Pregnant woman protected by law (guardianship, curatorship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS)This intervention consists of analyzing the amniotic fluid proteome using capillary electrophoresis coupled with mass spectrometry (CE-MS). The goal is to evaluate a predefined 98-peptide signature that predicts postnatal kidney function in fetuses with bilateral congenital anomalies of the kidney and urinary tract. Unlike standard prenatal assessments based on ultrasound and fetal biochemistry, this method provides a molecular-based prognostic tool to improve decision-making regarding pregnancy management and neonatal care | Other | Proteomic-Based Prediction of Postnatal Kidney Function in Fetuses with Bilateral CAKUT |
Primary outcome
Sensitivity and specificity of the test in the evaluation of renal survival (need for dialysis) and patient survival at 2 years of life.
Time frame: 2 years of age
Renal survival is defined as the absence of end-stage renal disease (ESRD) requiring dialysis by 2 years of age. Patient survival is defined as the child being alive at 2 years. Renal function is assessed through clinical follow-up, including serum creatinine measurements and estimated glomerular filtration rate (eGFR) using the Schwartz formula. Dialysis initiation is determined based on standard clinical criteria for ESRD. Survival status is confirmed through medical records and follow-up visits. This outcome aims to validate the predictive value of the 98-peptide amniotic fluid signature for postnatal kidney function in CAKUT fetuses.
2 secondary outcomes
Sensitivity and specificity of the test in the evaluation of postnatal renal function estimated by the Schwartz formula and his serum creatinine
Time frame: At months 1, 6, 12, and 24 postnatally
Severity score result rendering time
Time frame: up to 2 weeks after sample collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amniotic Fluid Proteomic Analysis Using Capillary Electrophoresis-Mass Spectrometry (CE-MS) in people with Kidney Diseases, run by University Hospital, Toulouse 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas SIMON (05 34 55 84 58, simon.t@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the test in the evaluation of renal survival (need for dialysis) and patient survival at 2 years of life. (time frame: 2 years of age). 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 4 May 2026.