- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411937
Kynurenine Concentrations During Pregnancy in Women With or Without Chronic Kidney Disease - A Prospective Multicenter Study (KIDNEY-MOM)
February 9, 2026 updated by: CHU de Reims
Concentrations of Kynurenine During Pregnancy in Women With or Without Chronic Kidney Disease: A Prospective Multicenter Study
Chronic kidney disease (CKD) affects more than 10% of the population worldwide and represents the second most important risk factor for preeclampsia, a life-threatening complication of pregnancy responsible for approximately 80,000 maternal and 500,000 perinatal deaths each year.
Experimental studies have suggested a causal link between CKD, relative kynurenine deficiency during pregnancy, and preeclampsia development.
Kynurenine, a tryptophan metabolite, plays a central role at the materno-fetal interface, supporting placental energy production, maternal-fetal immune tolerance, and placental perfusion.
This study will prospectively assess and compare longitudinal kynurenine concentrations in pregnant women with and without CKD, and evaluate their associations with maternal and fetal outcomes.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter, prospective cohort study including 204 pregnant women, with or without chronic kidney disease (CKD stages 2 to 4).
Participants will be enrolled before 14 weeks of gestation.
Blood samples (14 mL) will be collected at the 1st, 2nd, and 3rd trimesters and 2 months postpartum for kynurenine measurement, centrally analyzed at CHU Reims using LC-MS/MS.
Additional data include maternal demographics, medical and obstetric history, anthropometry, laboratory data (creatinine, hemoglobin, hematocrit, proteinuria), blood pressure, ultrasound (growth parameters, umbilical artery Doppler), and maternal-fetal outcomes (preeclampsia, gestational hypertension, HELLP, hemorrhage, SGA, prematurity, mortality).
The primary objective is to compare kynurenine concentrations in the 3rd trimester between women with and without CKD.
Secondary objectives include describing longitudinal kynurenine evolution, its association with maternal-fetal outcomes, and modeling kynurenine needs during pregnancy in CKD.
Study Type
Interventional
Enrollment (Estimated)
204
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vincent DUPONT
- Phone Number: 0033 03 26 78 76 41
- Email: vdupont@chu-reims.fr
Study Locations
-
-
-
Reims, France
- Marie Muller
-
Contact:
- Vincent DUPONT
- Phone Number: 0033 03 26 78 76 41
- Email: vdupont@chu-reims.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult pregnant women <14 weeks of amenorrhea
- With or without CKD stage 2-4 (eGFR 15-89 mL/min/1.73m², diagnosed before pregnancy)
- Written informed consent
- Affiliation to a social security system
Exclusion Criteria:
- Multiple pregnancy
- Kidney transplantation
- Persons under guardianship or legal protection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Women with chronic kidney disease
|
A 14ml blood sample will be collected during the first second and third trimesters of pregnancy and at 2 months (+ 1 month post partum)
|
|
Other: Women without chronic kidney disease
|
A 14ml blood sample will be collected during the first second and third trimesters of pregnancy and at 2 months (+ 1 month post partum)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Kynurenine concentration at the 3rd trimester (32±1 weeks) in women with and without CKD
Time Frame: 32±1 weeks
|
32±1 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Kynurenine concentrations at 1st, 2nd, 3rd trimesters and 2 months postpartum in women with and without CKD
Time Frame: at 9 months
|
at 9 months
|
|
preeclampsia
Time Frame: at 6 months
|
at 6 months
|
|
gestational hypertension
Time Frame: at 6 months
|
at 6 months
|
|
HELLP syndrome
Time Frame: at 6 months
|
at 6 months
|
|
postpartum hemorrhage
Time Frame: at 6 months
|
at 6 months
|
|
small-for-gestational-age
Time Frame: at 6 months
|
at 6 months
|
|
prematurity
Time Frame: at 6 months
|
at 6 months
|
|
fetal/neonatal mortality
Time Frame: at 6 months
|
at 6 months
|
|
Modeling of kynurenine needs across pregnancy in CKD women mean kynurenine concentration
Time Frame: at 6 months
|
at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2026
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
May 1, 2029
Study Registration Dates
First Submitted
February 9, 2026
First Submitted That Met QC Criteria
February 9, 2026
First Posted (Actual)
February 17, 2026
Study Record Updates
Last Update Posted (Actual)
February 17, 2026
Last Update Submitted That Met QC Criteria
February 9, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Pregnancy Complications
- Renal Insufficiency
- Hypertension, Pregnancy-Induced
- Pathological Conditions, Signs and Symptoms
- Pre-Eclampsia
- Kidney Diseases
- Renal Insufficiency, Chronic
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- PR26006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Kidney Diseases
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
Texas A&M UniversityWithdrawnChronic Kidney FailureUnited States
-
University of the State of Santa CatarinaUnknownKidney Diseases | Chronic Kidney Diseases | Hemodialysis | Chronic Renal Insufficiency | Renal Dialysis | Chronic Kidney Insufficiency | Chronic Renal DiseasesBrazil
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
-
Pharmagest InteractiveCompletedChronic Kidney DiseasesFrance
Clinical Trials on Blood sampling
-
Institut du Cancer de Montpellier - Val d'AurelleRecruitingGlioma | Sarcoma | Cancer | Breast Cancer | Colon Cancer | Lung CancersFrance
-
Medical University of GrazJoanneum Research Forschungsgesellschaft mbHCompleted
-
CardioRenalCompletedPotassium MeasurementBelgium
-
Fondazione Policlinico Universitario Agostino Gemelli...Active, not recruiting
-
Centre Hospitalier Universitaire DijonCompletedPatients With Intellectual Disabilities Without an Obvious Clinical Diagnosis | Patients With Normal Array CGH and Previous Negative Genetic Investigations (WES-solo or WES-trio)France
-
Assistance Publique - Hôpitaux de ParisURC Necker Cochin, FranceCompletedSepsis | Acute Circulatory FailureFrance
-
Royal Surrey County Hospital NHS Foundation TrustCompletedThyroid Carcinoma | Thyroid Cancer | Cancer of the Thyroid | Cancer of ThyroidUnited Kingdom
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Rennes University HospitalCompletedMultiple SclerosisFrance
-
Institut PasteurSanofi Pasteur, a Sanofi Company; Institut Pasteur of Cote d'IvoireCompletedBordetella Pertussis, Whooping CoughCôte D'Ivoire