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NCT Number: NCT01893710

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, 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.

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Key information

About this study

Please see study protocol and

http://www.pedpd.org

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 0 to 90 years
  • CKD 5D, peritoneal dialysis and
  • Patients with normal renal function and elective abdominal surgery due to limited abdominal pathology (such as hernia repair, gallstones….)
  • Patients post PD and post Tx
  • Oral and written consent
  • Ability to consent of the adult patient and of the parents and legal guardian of patients not yet of legal age, respectively

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

Treatment and study plan

Biopsy sampling

Procedure

Two parietal peritoneal samples, each 1 cm² x 0.3 cm in depth and three omental tissue samples, each 1 cm² in size will be obtained.

Biopsy sampling will be performed in all groups. This is an observational not an interventional trial.

Primary outcomes

  1. Peritoneal vasculopathy (lumen vessel ratio)

    Time frame: Two years (Mean PD treatment time)

    Digital quantification of degree of vasculopathy, i.e the lumen vessel ratio. Healthy children have a L/V ratio of about 0.7. lower values represent vasculopathy with lumen narrowing, 0 is complete obliteration of the vessel.

    This measurements will be accompanied by molecular analysis of pathomechanisms (including omics Technology)

Secondary outcomes

  1. Number of vessels per peritoneal membrane area (per mm²)

    Time frame: at time of catheter insertion, intercurrent abdominal surgery and at time of renal transplantation

    Digital histomorphometry of small vessel density per mm² submesothelial section area analysed.

Other outcomes

  1. Submesothelial thickness (µm)

    Time frame: 2 years (average PD duration)

    Digital imaging analysis of submesothelial thickness as a marker of peritoneal fibrosis (distance between mesothelium and adjacent muscle/adipos tissue)

  2. Submesothelial lymphocyte, macrophage, MMT cell count

    Time frame: 2 years (mean PD duration)

    Quantification of peritoneal leucocyte Infiltration, i.e. number of CD45 positive lymphocytes and CD68 positive macrophages per mm² of submesothelial section area . The number of cells that underwent mesothelial-mesenchymal transition per mm² submesothelial section are quantified by immunohistochemical co-staining of mesothelial and fibroblast marker (cytokeratin and FSP1).

  3. Peritoneal VEGF and pSMAD abundance

    Time frame: 2 years (mean PD duration)

    Key cytokines involved in peritoneal membrane transformation will be measured immunohistochemically. These are VEGF and TGF-beta induced p-SMAD (%positive area per section area analysed).

Study contacts

Contact information is provided by the study sponsor or research team.

Claus P Schmitt, Prof

CONTACT

[email protected]

+49 6221 56 ext. 39313

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Important dates

Study start
2011
Primary completion
2028
Study completion
2028
First posted
Jul 9, 2013
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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