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: Review the eligibility criteria below.
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 1 Day to 90 Years
🧪 Interventions in This Study
- biopsy sampling (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 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,
📞 Contact the Study Coordinator
Phone: +49 6221 56
Email: claus.peter.schmitt@med.uni-heidelberg.de
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.