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ClinicalTrials.gov ID

NCT01893710

Lead Sponsor

Heidelberg UniversityOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

500Estimated

Last Update Posted

Apr 30, 2026Actual

Start Date

Feb 1, 2011Actual

Primary Completion Date

Oct 1, 2028Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

International (Pediatric) Peritoneal Biobank

Brief Summary

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.

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.

Detailed Description

Please see study protocol and

http://www.pedpd.org

• Kidney Failure, Chronic
• Peritoneal Dialysis Complication
• Transplantation
• Healthy

• biopsy sampling

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria:

• Abdominal adhesions, malformation and inflammation beyond PD induced changes
• Patients with disseminated tumour disease
• Patients with critical heart failure and other medical conditions, where the additional procedure may confer an increased increase risk
• Pregnancy
• Preterm babies (below 37 weeks of gestational age)
• Serum hemoglobin < 10 g/dl in newborns and < 8 g/dl in children and adults

Observational Model

Other

Time Perspective

Prospective

Lead Sponsor

Heidelberg UniversityOTHER

Johan.VandeWalle@uzgent.be+32 93322483