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.
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
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.
- Conditions
- Chronic Kidney Disease (CKD)
- 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 group | Role | What they receive |
|---|---|---|
| Children with non-dialysis chronic kidney disease (CKD) stages 1-2 | Children with non-dialysis chronic kidney disease (CKD) stages 1-2 Receives: Other: Blood samples collection | |
| Children with non-dialysis chronic kidney disease (CKD) stages 4-5 | Children with non-dialysis chronic kidney disease (CKD) stages 4-5 Receives: Other: Blood samples collection | |
| Children receiving peritoneal dialysis | Children receiving peritoneal dialysis Receives: Other: Blood samples collection | |
| Children receiving pediatric hemodialysis with pre-dilution hemodiafiltration | Children receiving pediatric hemodialysis with pre-dilution hemodiafiltration Receives: Other: Blood samples collection | |
| Children receiving pediatric hemodialysis with post-dilution hemodiafiltration | Children 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.
Comparison of blood PFOA concentrations between groups
Measured: Day 0
Secondary outcomes (3)
Comparison blood PFAS concentrations between groups
Measured: Day 0
Blood PFOA concentrations at the beginning and end of hemodialysis session using pre- and post-dilution hemodiafiltration
Measured: Day 0
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.
- First posted13 Aug 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Apr 2028 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine BACCHETTA, PU-PH, MD, Principal investigator, Hospices Civils de Lyon
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Endocrine Disruptors Accumulate in Children Undergoing Paediatric Dialysis?
- ClinicalTrials.gov ID
- NCT07763483
- Acronym / sponsor ID
- PedDIA-TOX / 69HCL26_0664
- Conditions
- Chronic Kidney Disease (CKD)
- Keywords
- Endocrine disruptors, Paediatric dialysis, Chronic kidney disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Apr 2028 (estimated)
- Study completion
- 10 Apr 2028 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Children with non-dialysis chronic kidney disease (CKD) stages 1-2 | – | Other: Blood samples collectionChildren with non-dialysis chronic kidney disease (CKD) stages 1-2 |
| Children with non-dialysis chronic kidney disease (CKD) stages 4-5 | – | Other: Blood samples collectionChildren with non-dialysis chronic kidney disease (CKD) stages 4-5 |
| Children receiving peritoneal dialysis | – | Other: Blood samples collectionChildren receiving peritoneal dialysis |
| Children receiving pediatric hemodialysis with pre-dilution hemodiafiltration | – | Other: Blood samples collectionChildren receiving pediatric hemodialysis with pre-dilution hemodiafiltration |
| Children receiving pediatric hemodialysis with post-dilution hemodiafiltration | – | Other: Blood samples collectionChildren receiving pediatric hemodialysis with post-dilution hemodiafiltration |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples collectionBlood samples collection | Other | Children receiving pediatric hemodialysis with post-dilution hemodiafiltration, Children receiving pediatric hemodialysis with pre-dilution hemodiafiltration, Children receiving peritoneal dialysis, Children with non-dialysis chronic kidney disease (CKD) stages 1-2, Children with non-dialysis chronic kidney disease (CKD) stages 4-5 |
Primary outcome
Comparison of blood PFOA concentrations between groups
Time frame: Day 0
3 secondary outcomes
Comparison blood PFAS concentrations between groups
Time frame: Day 0
Blood PFOA concentrations at the beginning and end of hemodialysis session using pre- and post-dilution hemodiafiltration
Time frame: Day 0
Blood PFAS concentrations at the beginning and end of hemodialysis session using pre- and post-dilution hemodiafiltration
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
Related trials for Chronic Kidney Disease (CKD)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justine BACCHETTA, PU-PH, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
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.