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International (Pediatric) Peritoneal Biobank

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Primary completion date: Oct 2028 to Oct 1, 2028
    • Study completion date: Dec 2028 to Dec 31, 2028
    • Start date: Feb 2011 to Feb 1, 2011
    • Site contacts updated at 1 of 26 sites
    v13
  2. Minor 3 versions Re-verified since Jun 2, 2022, no change to tracked fieldsv10-v12
  3. Minor Study sites: 25 to 26v9
  4. Notable Primary completion date: Dec 2019 to Oct 2028v8 Show 9 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 400 to 500
    • Study sites: 27 to 25
    • Study completion date: Mar 2020 to Dec 2028
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study arms: 1 to 4
    • Study description shortened, about 1 word
    • Study title shortened, about 1 word
  5. Notable Primary completion date: Dec 2017 to Dec 2019
    • Study completion date: Dec 2017 to Mar 2020
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Primary and study completion dates: Feb 2016 to Dec 2017v5
  3. Minor Eligibility criteria expanded, about 10 wordsv4
  4. Minor Study sites: 25 to 27v3
  5. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT01893710
Lead Sponsor Heidelberg University
Conditions
(from sponsor)
Kidney Failure, Chronic, Peritoneal Dialysis Complication, Transplantation, Healthy
Related terms Kidney Failure, Chronic, Renal Insufficiency, Chronic, Vascular Diseases
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov