International Pediatric Peritoneal Biobank for Kidney Failure

This observational study is collecting tissue samples to understand how the lining of the abdomen (peritoneal membrane) changes in children and adults with kidney failure who are on peritoneal dialysis (PD). Researchers are interested in how the membrane transforms over time, leading to issues like fibrosis (scarring) and vasculopathy (blood vessel disease), which can cause PD to fail. They are also studying people with normal kidney function who are having abdominal surgery. The goal is to understand these changes, especially in children where aging or diabetes are not factors. The study plans to enroll 500 participants aged 1 day to 90 years.

Study design
This is an observational study with a planned enrollment of 500 participants. It is not testing a new treatment, but rather observing changes in the body.
What's involved
You would have two small tissue samples taken from the lining of your abdomen and three from the omentum (a fatty tissue in the abdomen) during surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, peritoneal vasculopathy, will be measured at two years (mean PD treatment time).

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NCT01893710

International (Pediatric) Peritoneal Biobank

Recruiting
Not specifiedAges 1–90Observational
Heidelberg University
~500 participants
Updated 2026-04-30 on ClinicalTrials.gov
What's tested:biopsy sampling

At a glance

Recruiting sites
17 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peritoneal vasculopathy (lumen vessel ratio)
Measured over Two years (Mean PD treatment time)
Kidney Failure, Chronic
Peritoneal Dialysis Complication
Transplantation
Healthy
26 sites across 18 states
Germany5
Italy3
France2
Turkey (Türkiye)2
Alabama1
Missouri1
Pennsylvania1
Austria1
  • Claus P Schmitt, MD · PRINCIPAL_INVESTIGATOR · University of Heidelberg, Center for Pediatric and Adolescent Medicine

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Eligibility criteria

Inclusion

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

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
  • Peritoneal vasculopathy (lumen vessel ratio)Two years (Mean PD treatment time)

    Digital quantification of degree of vasculopathy, i.e the lumen vessel ratio. Healthy children have a L/V ratio of about 0.7. lower values represent vasculopathy with lumen narrowing, 0 is complete obliteration of the vessel. This measurements will be accompanied by molecular analysis of pathomechanisms (including omics Technology)