Collects belly lining tissue samples from children on peritoneal dialysis
Collects belly lining tissue samples from children with kidney failure.
Key facts
- Who runs it
- Heidelberg University
- Where
- Lyon and Strasbourg, FranceSee the 2 sitesAlso in 14 other countries, 24 sites
- Trial code
- Registry title
- International (Pediatric) Peritoneal Biobank
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 1 Feb 2011
- Expected to end
- 31 Dec 2028
- Type of study
- Observational, 4 groups
- Treatments tested
- biopsy sampling
- Record updated
- 30 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and adults on peritoneal dialysis for kidney failure. It also takes people with normal kidney function who need planned belly surgery, and people who were on peritoneal dialysis and then had a kidney transplant.
- Age
- 0 to 90 years (from 1 Day to 90 Years)
- Sex
- All sexes can join.
- Disease stage
- Kidney failure (CKD stage 5D) on peritoneal dialysis; or normal kidney function with planned belly surgery for a limited problem such as hernia repair or gallstones; or after peritoneal dialysis and kidney transplant.
Main reasons for not taking part
- Belly adhesions, malformation or inflammation beyond changes caused by peritoneal dialysis
- Disseminated tumour disease
- Critical heart failure or other conditions where the extra procedure may raise risk
- Pregnancy
- Preterm babies (below 37 weeks of gestational age)
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Age 0 to 90 years
- CKD 5D, peritoneal dialysis and
- Patients with normal renal function and elective abdominal surgery due to limited abdominal pathology (such as hernia repair, gallstones….)
- Patients post PD and post Tx
- Oral and written consent
- Ability to consent of the adult patient and of the parents and legal guardian of patients not yet of legal age, respectively
Who cannot take part
- Patients with disseminated tumour disease
- Patients with critical heart failure and other medical conditions, where the additional procedure may confer an increased increase risk
- Serum hemoglobin < 10 g/dl in newborns and < 8 g/dl in children and adults
- Preterm babies (below 37 weeks of gestational age)
- Abdominal adhesions, malformation and inflammation beyond PD induced changes
- Pregnancy
Where in France
Also in 14 other countries, 24 sites
- Service de Néphrologie Pédiatrique, Hôpital Femme Mere EnfantLyon, FranceContact: Bruno Ranchin, MDTaking people
- University Children's HospitalStrasbourg, FranceContact: Ariane Zaloszyc, MDTaking people
About the trial
What the trial wants to find out
Within few years the peritoneal membrane of adult peritoneal dialysis (PD) patients undergoes substantial morphological transformation, including progressive fibrosis, vasculopathy and neoangiogenesis. Ultrafiltration capacity steadily declines and ultimately results in PD failure. In children, peritoneal biopsies demonstrating PD associated alterations have not yet been obtained. They, however, should be particularly informative, since secondary tissue and vascular pathology related to ageing or diabetes is absent.
Read full original descriptionShow less
An international, prospective peritoneal membrane biopsy study in children on PD will therefore be performed. Biopsies will be obtained at time of PD catheter insertion, on occasion of intercurrent abdominal surgery (e.g. hernia repair, catheter exchange) and at time of renal transplantation. Quantitative histomorphometry and tissue protein expression analyses will be correlated with time integrated PD treatment modalities and functional characteristics as well as inflammatory and cardiovascular comorbidity surrogate parameter. Blood will be obtained during clinical routine sampling. Biopsies will be obtained during clinically indicated operations, without substantially increasing operation time and associated surgical risks. The detailed histomorphometry of the PD membrane will give additional information, potentially impacting on the individual PD regime.
3/2018: The analyses of the pediatric PD biopsy demonstrated early and major transformation of the peritoneal membrane with neutral pH low GDP fluids, and significant vasculopathy already in children with CKD stage 5, further progressing with PD. The underlying mechanisms are partly understood, only. In view of these major findings and the numerous open questions, collection of biosamples will be continued in children and also in adult PD patients. The following questions will be addressed: Molecular counterparts of peritoneal semi-permeability, solute and water transport (beyond AQP1), pathomechanisms and molecular and functional impact of peritoneal transformation with low and high GDP fluids, and the respective pathomechanisms and molecular and functional impact of vascular disease in CKD and with different PD fluids. The impact of renal transplantation following PD will be assessed in a subgroup of patients with tenckhoff catheter removal several weeks after transplantation and a functioning graft.
The 4 groups in the trial
- Control
'Biopsy sampling': Peritoneal biopsies without kidney disease, i.e. diseases not related to the kidney and not affecting the peritoneum. This group is accomplished.
- chronic kidney disease
Samples will obtained from patients with chronic kidney disease stage 5 (at time of catheter Insertion)
Treatment: biopsy sampling
- Peritoneal dialysis
Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.
Treatment: biopsy sampling
- Post PD and with functioning graft
Samples will also be collected and analysed from patients with renal transplantation after PD at time of and tenckhoff catheter removal several weeks after Tx or other intercurrent abdominal surgery.
Treatment: biopsy sampling
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- International (Pediatric) Peritoneal Biobank
- Plain-language title
- Collects belly lining tissue samples from children on peritoneal dialysisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 30 April 2026