International (Pediatric) Peritoneal Biobank
2 other identifiers
observational
500
15 countries
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2013
CompletedFirst Posted
Study publicly available on registry
July 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
April 30, 2026
December 1, 2024
17.7 years
June 27, 2013
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peritoneal vasculopathy (lumen vessel ratio)
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)
Two years (Mean PD treatment time)
Secondary Outcomes (1)
Number of vessels per peritoneal membrane area (per mm²)
at time of catheter insertion, intercurrent abdominal surgery and at time of renal transplantation
Other Outcomes (3)
Submesothelial thickness (µm)
2 years (average PD duration)
Submesothelial lymphocyte, macrophage, MMT cell count
2 years (mean PD duration)
Peritoneal VEGF and pSMAD abundance
2 years (mean PD duration)
Study Arms (4)
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)
Peritoneal dialysis
Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.
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.
Interventions
Two parietal peritoneal samples, each 1 cm² x 0.3 cm in depth and three omental tissue samples, each 1 cm² in size will be obtained. Biopsy sampling will be performed in all groups. This is an observational not an interventional trial.
Eligibility Criteria
See eligibility data
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
The Children´s Hospital of Philadelphia
Narberth, Pennsylvania, 19104, United States
Department of Pediatrics, Medical University Vienna
Vienna, 1090, Austria
UZ Ghent
Ghent, 9890, Belgium
University Children's Hospital
Prague, 15006, Czechia
Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant
Lyon, 69677, France
University Children's Hospital
Strasbourg, 67098, France
Department of Medicine I (Nephrology), University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
University Children's Hospital
Berlin, 10117, Germany
University Children's Hospital
Cologne, 50931, Germany
University Children's Hospital
Essen, 45122, Germany
UKE, University Children´s Hospital
Hamburg, 20251, Germany
KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg
Marburg, 35043, Germany
University Children's Hospital
Budapest, 1083, Hungary
University Children'Hospital
Genova, 16147, Italy
University Children's Hospital
Milan, 20122, Italy
Pediatric Nephrology, Dialysis and Transplant Unit
Padova, 35128, Italy
University children's Hospital
Vilnius, 08406, Lithuania
Paediatric CAPD unit, Kuala Lumpur Hospital
Kuala Lumpur, 50586, Malaysia
Krakow, Jagiellonian University Medical College
Krakow, 30663, Poland
Hospital Universitario Materno-Infantil Vall d' Hebron
Barcelona, 08035, Spain
Karolinska University Hospital
Stockholm, 17176, Sweden
Children's Hospital, Inselspital, Bern University Hospital and University of Bern
Bern, 3010, Switzerland
University Children's Hospital
Adana, 01330, Turkey (Türkiye)
Cerrahpasa School of Medicine
Istanbul, 34303, Turkey (Türkiye)
Related Publications (3)
Levai E, Marinovic I, Bartosova M, Zhang C, Schaefer B, Jenei H, Du Z, Drozdz D, Klaus G, Arbeiter K, Romero P, Schwenger V, Schwab C, Szabo AJ, Zarogiannis SG, Schmitt CP. Human peritoneal tight junction, transporter and channel expression in health and kidney failure, and associated solute transport. Sci Rep. 2023 Oct 13;13(1):17429. doi: 10.1038/s41598-023-44466-z.
PMID: 37833387DERIVEDCatar RA, Bartosova M, Kawka E, Chen L, Marinovic I, Zhang C, Zhao H, Wu D, Zickler D, Stadnik H, Karczewski M, Kamhieh-Milz J, Jorres A, Moll G, Schmitt CP, Witowski J. Angiogenic Role of Mesothelium-Derived Chemokine CXCL1 During Unfavorable Peritoneal Tissue Remodeling in Patients Receiving Peritoneal Dialysis as Renal Replacement Therapy. Front Immunol. 2022 Feb 4;13:821681. doi: 10.3389/fimmu.2022.821681. eCollection 2022.
PMID: 35185912DERIVEDBartosova M, Zhang C, Schaefer B, Herzog R, Ridinger D, Damgov I, Levai E, Marinovic I, Eckert C, Romero P, Sallay P, Ujszaszi A, Unterwurzacher M, Wagner A, Hildenbrand G, Warady BA, Schaefer F, Zarogiannis SG, Kratochwill K, Schmitt CP. Glucose Derivative Induced Vasculopathy in Children on Chronic Peritoneal Dialysis. Circ Res. 2021 Aug 20;129(5):e102-e118. doi: 10.1161/CIRCRESAHA.121.319310. Epub 2021 Jul 8.
PMID: 34233458DERIVED
Related Links
Biospecimen
Parietal ond omental peritoneal membrane specimen will be collected in all groups
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claus P Schmitt, MD
University of Heidelberg, Center for Pediatric and Adolescent Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 9, 2013
Study Start
February 1, 2011
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
April 30, 2026
Record last verified: 2024-12