Actively Recruiting
International (Pediatric) Peritoneal Biobank
Led by Heidelberg University · Updated on 2026-04-30
500
Participants Needed
26
Research Sites
934 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
International (Pediatric) Peritoneal Biobank
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0 to 90 years
- Diagnosis of chronic kidney disease stage 5D or peritoneal dialysis treatment
- Patients with normal kidney function undergoing elective abdominal surgery for limited abdominal conditions such as hernia repair or gallstones
- Patients after peritoneal dialysis and after kidney transplantation
- Oral and written consent obtained
- Ability to consent by adult patients or by parents/legal guardians for minors
You will not qualify if you...
- Presence of abdominal adhesions, malformations, or inflammations beyond changes caused by peritoneal dialysis
- Patients with widespread tumor disease
- Patients with critical heart failure or other medical conditions that increase risk from additional procedures
- Pregnancy
- Preterm babies born before 37 weeks of gestation
- Newborns with hemoglobin less than 10 g/dl or children and adults with hemoglobin less than 8 g/dl
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
3
The Children´s Hospital of Philadelphia
Narberth, Pennsylvania, United States, 19104
Active, Not Recruiting
4
Department of Pediatrics, Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
5
UZ Ghent
Ghent, Belgium, 9890
Actively Recruiting
6
University Children's Hospital
Prague, Czechia, 15006
Actively Recruiting
7
Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant
Lyon, France, 69677
Actively Recruiting
8
University Children's Hospital
Strasbourg, France, 67098
Actively Recruiting
9
Department of Medicine I (Nephrology), University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
10
University Children's Hospital
Berlin, Germany, 10117
Active, Not Recruiting
11
University Children's Hospital
Cologne, Germany, 50931
Actively Recruiting
12
University Children's Hospital
Essen, Germany, 45122
Actively Recruiting
13
UKE, University Children´s Hospital
Hamburg, Germany, 20251
Actively Recruiting
14
KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg
Marburg, Germany, 35043
Actively Recruiting
15
University Children's Hospital
Budapest, Hungary, 1083
Actively Recruiting
16
University Children'Hospital
Genova, Italy, 16147
Active, Not Recruiting
17
University Children's Hospital
Milan, Italy, 20122
Actively Recruiting
18
Pediatric Nephrology, Dialysis and Transplant Unit
Padova, Italy, 35128
Active, Not Recruiting
19
University children's Hospital
Vilnius, Lithuania, 08406
Actively Recruiting
20
Paediatric CAPD unit, Kuala Lumpur Hospital
Kuala Lumpur, Malaysia, 50586
Active, Not Recruiting
21
Krakow, Jagiellonian University Medical College
Krakow, Poland, 30663
Actively Recruiting
22
Hospital Universitario Materno-Infantil Vall d' Hebron
Barcelona, Spain, 08035
Actively Recruiting
23
Karolinska University Hospital
Stockholm, Sweden, 17176
Active, Not Recruiting
24
Children's Hospital, Inselspital, Bern University Hospital and University of Bern
Bern, Switzerland, 3010
Active, Not Recruiting
25
University Children's Hospital
Adana, Turkey (Türkiye), 01330
Actively Recruiting
26
Cerrahpasa School of Medicine
Istanbul, Turkey (Türkiye), 34303
Active, Not Recruiting
Research Team
C
Claus P Schmitt, Prof
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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