NCT07411937

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Mar 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026May 2029

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

February 17, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

February 9, 2026

Last Update Submit

February 9, 2026

Conditions

Keywords

kidney diseasepregnancypreeclampsiakynureninematernal outcomesfetal outcomes

Outcome Measures

Primary Outcomes (1)

  • Kynurenine concentration at the 3rd trimester (32±1 weeks) in women with and without CKD

    32±1 weeks

Secondary Outcomes (9)

  • Kynurenine concentrations at 1st, 2nd, 3rd trimesters and 2 months postpartum in women with and without CKD

    at 9 months

  • preeclampsia

    at 6 months

  • gestational hypertension

    at 6 months

  • HELLP syndrome

    at 6 months

  • postpartum hemorrhage

    at 6 months

  • +4 more secondary outcomes

Study Arms (2)

Women with chronic kidney disease

OTHER
Other: Blood sampling

Women without chronic kidney disease

OTHER
Other: Blood sampling

Interventions

A 14ml blood sample will be collected during the first second and third trimesters of pregnancy and at 2 months (+ 1 month post partum)

Women with chronic kidney diseaseWomen without chronic kidney disease

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Multiple pregnancy
  • Kidney transplantation
  • Persons under guardianship or legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie MULLER

Reims, France

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicPre-EclampsiaKidney Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHypertension, Pregnancy-InducedPregnancy Complications

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

February 17, 2026

Record last verified: 2026-01

Locations