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NCT01893710 · ClinicalTrials.gov registry record
International (Pediatric) Peritoneal Biobank
A clinical trial of Healthy and Kidney Failure, Chronic, sponsored by Heidelberg University.
- Recruiting
- Registry status
- 500
- Enrollment target
- 20
- Study locations
NCT01893710 is a study of Healthy and Kidney Failure, Chronic that is actively recruiting participants, run by Heidelberg University. The registered enrollment target is 500 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (23% lower). The trial reports 20 study locations across 5 states.
The verdict
NCT01893710, a study of Healthy and Kidney Failure, Chronic, is actively recruiting participants, sponsored by Heidelberg University.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
- 20
- Study locations
Study 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), pathomechani
Conditions Studied
Interventions
- PROCEDURE biopsy sampling
Study Locations (20)
Other
- 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
- 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 - Padua
- University children's Hospital - Vilnius
- Paediatric CAPD unit, Kuala Lumpur Hospital - Kuala Lumpur
Alabama
- University of Alabama at Birmingham - Birmingham
Missouri
- Children's Mercy Hospital - Kansas City
Pennsylvania
- The Children´s Hospital of Philadelphia - Narberth
Baden-Wurttemberg
- Department of Medicine I (Nephrology), University of Heidelberg - Heidelberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2011-02 |
| Est. Completion | 2028-12 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01893710
The ClinicalTrials.gov registry entry for NCT01893710 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (23% lower). The listed sponsor is Heidelberg University, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which biopsy sampling is the first listed.
NCT01893710 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, Alabama, Missouri.
Frequently Asked Questions
What is clinical trial NCT01893710 about?
NCT01893710 is a clinical study titled "International (Pediatric) Peritoneal Biobank". 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, peri...
What is the current status of trial NCT01893710?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2011-02. Estimated completion is 2028-12.
What conditions does trial NCT01893710 study?
This clinical trial studies the following conditions: Healthy, Kidney Failure, Chronic, Peritoneal Dialysis Complication, Transplantation.
What interventions are being tested in trial NCT01893710?
The interventions under investigation include: biopsy sampling (PROCEDURE).
Who is sponsoring clinical trial NCT01893710?
This trial is sponsored by Heidelberg University, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01893710 being conducted?
This trial has 20 study locations across Alabama, Missouri, Pennsylvania, Baden-Wurttemberg. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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