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Clinical Trials/NCT07763483
NCT07763483Not yet recruitingNot Applicable

Do Endocrine Disruptors Accumulate in Children Undergoing Paediatric Dialysis?

Hospices Civils de Lyon1 site in 1 country15 target enrollmentStarted: October 10, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
15
Locations
1
Primary Endpoint
Comparison of blood PFOA concentrations between groups

Study Overview

Brief Summary

The impact of the environment on health is becoming an increasingly important issue in public health policies. Endocrine disruptors (EDs) are substances or mixtures of substances found in many everyday products that interact with the body's endocrine functions. Although their mechanisms of action are not yet fully understood, mechanisms involving endocrine mimicry, antagonism, and epigenetic effects have been described.

The effects of the main endocrine disruptors on bone health remain poorly understood. Per- and polyfluoroalkyl substances (PFAS) constitute a large family of synthetic organic compounds used for their non-stick and heat-resistant properties. Perfluorooctanoic acid (PFOA) is a specific PFAS compound used in packaging materials and plastics. One of the known effects of PFAS is their interference with vitamin D through competition at its receptor, thereby reducing bone formation. In addition, PFAS decrease the proliferation of bone cells and reduce extracellular matrix synthesis.

From foetal development through adolescence, early life represents a critical period for bone formation. If environmental chemicals can interfere with this process in the general paediatric population, the accumulation of endocrine disruptors may also exert an additional deleterious effect in the context of chronic kidney disease-mineral and bone disorder (CKD-MBD). Indeed, patients with chronic kidney disease (CKD) have a higher incidence of fractures and present mineral, skeletal, and cardiovascular abnormalities whose pathophysiology is extremely complex. The potential impact of endocrine disruptors on the pathophysiology of CKD-MBD in children has never been evaluated, despite the fact that during dialysis sessions, blood repeatedly circulates through a circuit composed mainly of plastics and exposed to elevated temperatures.

In adult dialysis populations, PFAS exposure has been investigated, but the results are contradictory. In 2018, Liu et al. found no evidence of PFAS removal by haemodialysis. Conversely, studies by Liu et al. (2018) and Huang et al. (2023) demonstrated a significant reduction in PFAS concentrations in patients following haemodialysis sessions and compared with patients with chronic kidney disease not receiving dialysis. Both research groups suggested that PFAS levels in dialysis patients are significantly influenced by the composition and properties of the dialysis membranes used.

However, these studies were conducted exclusively in adults, who, by definition, do not have a growing skeleton, and were restricted to PFAS measurements. This is particularly relevant given that: (1) dialysis techniques are rapidly evolving, with hemodiafiltration increasingly replacing conventional haemodialysis and with different membrane types used in paediatric practice; and (2) children undergoing dialysis often require more frequent treatment sessions than adults. For example, according to the French national survey conducted on January 28, 2026, in preparation for discussions on a new dialysis reimbursement model, 25% of the 93 children receiving chronic haemodialysis underwent treatment more than three times per week. Furthermore, none of these studies assessed the impact of peritoneal dialysis, a modality that is relatively uncommon in adults but widely used in paediatrics, particularly among very young children.

These considerations have prompted us to evaluate PFAS serum concentrations in children with: (1) chronic kidney disease, (2) peritoneal dialysis, and (3) haemodialysis. This study is designed as a pilot project that may support the development of a larger-scale investigation depending on the results obtained.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
2 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Children aged 0 to 17 years (inclusive), followed in the Paediatric Nephrology Department of the Femme-Mère-Enfant Hospital, Hospices Civils de Lyon.
  • •No objection from the parents or legal guardian(s).
  • •Assent of the minor participant, when appropriate according to age and level of understanding
  • •For group 1: Children with non-dialysis chronic kidney disease (CKD) stages 1-2, weighing at least 5 kg.
  • •For group 2: Children with non-dialysis chronic kidney disease (CKD) stages 4-5, weighing at least 5 kg.
  • •For group 3: Children receiving peritoneal dialysis, weighing at least 5 kg.
  • •For group 4: Children receiving paediatric haemodialysis with pre-dilution hemodiafiltration, weighing at least 12 kg.
  • •For group 5: Children receiving paediatric haemodialysis with post-dilution hemodiafiltration, weighing at least 12 kg.

Exclusion Criteria

  • •Participation in another interventional research study with an exclusion period still ongoing on the day of inclusion and deemed by the investigator to potentially interfere with the present study.
  • •Individuals deprived of liberty by a judicial or administrative decision.

Arms & Interventions

Children with non-dialysis chronic kidney disease (CKD) stages 1-2

Children with non-dialysis chronic kidney disease (CKD) stages 1-2

Intervention: Blood samples collection (Other)

Children receiving peritoneal dialysis

Children receiving peritoneal dialysis

Intervention: Blood samples collection (Other)

Children with non-dialysis chronic kidney disease (CKD) stages 4-5

Children with non-dialysis chronic kidney disease (CKD) stages 4-5

Intervention: Blood samples collection (Other)

Children receiving pediatric hemodialysis with pre-dilution hemodiafiltration

Children receiving pediatric hemodialysis with pre-dilution hemodiafiltration

Intervention: Blood samples collection (Other)

Children receiving pediatric hemodialysis with post-dilution hemodiafiltration

Children receiving pediatric hemodialysis with post-dilution hemodiafiltration

Intervention: Blood samples collection (Other)

Outcomes

Primary Outcomes

Comparison of blood PFOA concentrations between groups

Time Frame: Day 0

Secondary Outcomes

  • Comparison blood PFAS concentrations between groups(Day 0)
  • Blood PFOA concentrations at the beginning and end of hemodialysis session using pre- and post-dilution hemodiafiltration(Day 0)
  • Blood PFAS concentrations at the beginning and end of hemodialysis session using pre- and post-dilution hemodiafiltration(Day 0)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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