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Chronic Kidney Disease (CKD)PedDIA-TOXNCT07763483

Do Endocrine Disruptors Accumulate in Children Undergoing Paediatric Dialysis?

An observational study of Chronic Kidney Disease (CKD), run by Hospices Civils de Lyon at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Chronic Kidney Disease (CKD)
What is being tested?
Blood samples collection
How many people
15 participants
Where
1 siteFrance
Study dates
10 Oct 2026to 10 Apr 2028
Phase
Observational
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 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Participants will be recruited from the Pediatric Nephrology Department of the Femme-Mère-Enfant Hospital, Hospices Civils de Lyon. A total of 15 patients will be enrolled in the study, distributed as follows: * 3 children with non-dialysis chronic kidney disease (CKD) stages 1-2 * 3 children with non-dialysis chronic kidney disease (CKD) stages 4-5 * 3 children receiving peritoneal dialysis * 3 children receiving paediatric haemodialysis with pre-dilution hemodiafiltration * 3 children receiving paediatric haemodialysis with post-dilution hemodiafiltration.

Who may be able to join

  • 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.

Who cannot join

  • 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.

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
  • Hôpital Femme-Mère-Enfant

    Bron, 69500

    Justine BACCHETTA, PU-PH, MD, +33 4 27 85 61 30, justine.bacchetta@chu-lyon.fr

    Sacha FLAMMIER, +33 4 72 68 13 49, sacha.flammier@chu-lyon.fr

Other trials in France

About this study

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.

Read more

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.

Being tested
Blood samples collection
Keywords
Endocrine disruptors, Paediatric dialysis, Chronic kidney disease
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood samples collectionOther

    Blood samples collection

Study groups in NCT07763483
Study groupRoleWhat they receive
Children with non-dialysis chronic kidney disease (CKD) stages 1-2Children with non-dialysis chronic kidney disease (CKD) stages 1-2
Receives: Other: Blood samples collection
Children with non-dialysis chronic kidney disease (CKD) stages 4-5Children with non-dialysis chronic kidney disease (CKD) stages 4-5
Receives: Other: Blood samples collection
Children receiving peritoneal dialysisChildren receiving peritoneal dialysis
Receives: Other: Blood samples collection
Children receiving pediatric hemodialysis with pre-dilution hemodiafiltrationChildren receiving pediatric hemodialysis with pre-dilution hemodiafiltration
Receives: Other: Blood samples collection
Children receiving pediatric hemodialysis with post-dilution hemodiafiltrationChildren receiving pediatric hemodialysis with post-dilution hemodiafiltration
Receives: Other: Blood samples collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of blood PFOA concentrations between groups

    Measured: Day 0

Secondary outcomes (3)
  1. Comparison blood PFAS concentrations between groups

    Measured: Day 0

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

    Measured: Day 0

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

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2026
  2. Study start10 Oct 2026 (estimated)
  3. Primary completion10 Apr 2028 (estimated)
  4. Study completion10 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07763483
Sponsor's protocol ID
69HCL26_0664
Other IDs
2026-A01616-45
Acronym
PedDIA-TOX
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease (CKD), run by Hospices Civils de Lyon 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 8 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Aug 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 Justine BACCHETTA, PU-PH, MD (+33 4 27 85 61 30, justine.bacchetta@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of blood PFOA concentrations between groups (time frame: Day 0). 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 17 Aug 2026.

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