Condition: Kidney Failure, Chronic · Peritoneal Dialysis Complication · Transplantation · Sponsor: Heidelberg University
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 periton…
This description comes directly from the study's public registry record.
Claus P Schmitt, Prof · +49 6221 56 · claus.peter.schmitt@med.uni-heidelberg.de
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| University of Alabama at Birmingham | Birmingham, Alabama, United States | Active Not Recruiting |
| Children's Mercy Hospital | Kansas City, Missouri, United States | Recruiting |
| The Children´s Hospital of Philadelphia | Narberth, Pennsylvania, United States | Active Not Recruiting |
| Department of Pediatrics, Medical University Vienna | Vienna, Austria | Recruiting |
| UZ Ghent | Ghent, Belgium | Recruiting |
| University Children's Hospital | Prague, Czechia | Recruiting |
| Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant | Lyon, France | Recruiting |
| University Children's Hospital | Strasbourg, France | Recruiting |
| Department of Medicine I (Nephrology), University of Heidelberg | Heidelberg, Baden-Wurttemberg, Germany | Recruiting |
| University Children's Hospital | Berlin, Germany | Active Not Recruiting |
| University Children's Hospital | Cologne, Germany | Recruiting |
| University Children's Hospital | Essen, Germany | Recruiting |
+ 14 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT01893710