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International (Pediatric) Peritoneal Biobank

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ClinicalTrials.gov Identifier: NCT01893710
Recruitment Status : Recruiting
First Posted : July 9, 2013
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Claus Peter Schmitt, Heidelberg University

Brief 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), 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.


Condition or disease Intervention/treatment
Kidney Failure, Chronic Peritoneal Dialysis Complication Transplantation Healthy Procedure: biopsy sampling

Detailed Description:

Please see study protocol and

http://www.pedpd.org


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: International (Pediatric) Peritoneal Biobank
Study Start Date : February 2011
Estimated Primary Completion Date : October 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control
'Biopsy sampling': Peritoneal biopsies without kidney disease, i.e. diseases not related to the kidney and not affecting the peritoneum. This group is accomplished.
chronic kidney disease
Samples will obtained from patients with chronic kidney disease stage 5 (at time of catheter Insertion)
Procedure: biopsy sampling

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.


Peritoneal dialysis
Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.
Procedure: biopsy sampling

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.


Post PD and with functioning graft
Samples will also be collected and analysed from patients with renal transplantation after PD at time of and tenckhoff catheter removal several weeks after Tx or other intercurrent abdominal surgery.
Procedure: biopsy sampling

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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).


Biospecimen Retention:   Samples With DNA
Parietal ond omental peritoneal membrane specimen will be collected in all groups


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
See eligibility data
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893710


Contacts
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Contact: Claus P Schmitt, Prof +49 6221 56 ext 39313 claus.peter.schmitt@med.uni-heidelberg.de

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Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Claus P Schmitt, MD University of Heidelberg, Center for Pediatric and Adolescent Medicine

Additional Information:
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Responsible Party: Claus Peter Schmitt, MD, Heidelberg University
ClinicalTrials.gov Identifier: NCT01893710     History of Changes
Other Study ID Numbers: IPPB Biobank
University of Heidelberg ( Other Identifier: University of Heidelberg, Medical Faculty )
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: October 2019
Keywords provided by Claus Peter Schmitt, Heidelberg University:
peritoneal dialysis
parietal peritoneum
omentum
chronic kidney disease
vasculopathy
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic