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NCT Number: NCT07763483

Do Endocrine Disruptors Accumulate in Children Undergoing Paediatric Dialysis?

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood samples collection

Other

Blood samples collection

Primary outcomes

  1. Comparison of blood PFOA concentrations between groups

    Time frame: Day 0

Secondary outcomes

  1. Comparison blood PFAS concentrations between groups

    Time frame: Day 0

  2. Blood PFOA concentrations at the beginning and end of hemodialysis sessions using pre- and post-dilution hemodiafiltration

    Time frame: Day 0

  3. Blood PFAS concentrations at the beginning and end of hemodialysis sessions using pre- and post-dilution hemodiafiltration

    Time frame: Day 0

Study contacts

Contact information is provided by the study sponsor or research team.

Justine BACCHETTA, PU-PH, MD

CONTACT

[email protected]

+33 4 27 85 61 30

Sacha FLAMMIER

CONTACT

[email protected]

+33 4 72 68 13 49

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: PedDIA-TOX

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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