International (Pediatric) Peritoneal Biobank (NCT01893710)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (7 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (26 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- Children's Mercy Hospital — Kansas City, Missouri
- The Children´s Hospital of Philadelphia — Narberth, Pennsylvania
- Department of Pediatrics, Medical University Vienna — Vienna,
- UZ Ghent — Ghent,
- University Children's Hospital — Prague,
- Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant — Lyon,
- University Children's Hospital — Strasbourg,
- Department of Medicine I (Nephrology), University of Heidelberg — Heidelberg, Baden-Wurttemberg
- University Children's Hospital — Berlin,
- University Children's Hospital — Cologne,
- University Children's Hospital — Essen,
- UKE, University Children´s Hospital — Hamburg,
- KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg — Marburg,
- University Children's Hospital — Budapest,
- University Children'Hospital — Genova,
- University Children's Hospital — Milan,
- Pediatric Nephrology, Dialysis and Transplant Unit — Padova,
- University children's Hospital — Vilnius,
- Paediatric CAPD unit, Kuala Lumpur Hospital — Kuala Lumpur,
- Krakow, Jagiellonian University Medical College — Krakow,
- Hospital Universitario Materno-Infantil Vall d' Hebron — Barcelona,
- Karolinska University Hospital — Stockholm,
- Children's Hospital, Inselspital, Bern University Hospital and University of Bern — Bern,
- University Children's Hospital — Adana,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.