Actively Recruiting

Age: 1Day - 90Years
All Genders
Healthy Volunteers
NCT01893710

International (Pediatric) Peritoneal Biobank

Led by Heidelberg University · Updated on 2026-04-30

500

Participants Needed

26

Research Sites

934 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

International (Pediatric) Peritoneal Biobank

Who Can Participate

Age: 1Day - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 0 to 90 years
  • Diagnosis of chronic kidney disease stage 5D or peritoneal dialysis treatment
  • Patients with normal kidney function undergoing elective abdominal surgery for limited abdominal conditions such as hernia repair or gallstones
  • Patients after peritoneal dialysis and after kidney transplantation
  • Oral and written consent obtained
  • Ability to consent by adult patients or by parents/legal guardians for minors
Not Eligible

You will not qualify if you...

  • Presence of abdominal adhesions, malformations, or inflammations beyond changes caused by peritoneal dialysis
  • Patients with widespread tumor disease
  • Patients with critical heart failure or other medical conditions that increase risk from additional procedures
  • Pregnancy
  • Preterm babies born before 37 weeks of gestation
  • Newborns with hemoglobin less than 10 g/dl or children and adults with hemoglobin less than 8 g/dl

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 26 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Active, Not Recruiting

2

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Actively Recruiting

3

The Children´s Hospital of Philadelphia

Narberth, Pennsylvania, United States, 19104

Active, Not Recruiting

4

Department of Pediatrics, Medical University Vienna

Vienna, Austria, 1090

Actively Recruiting

5

UZ Ghent

Ghent, Belgium, 9890

Actively Recruiting

6

University Children's Hospital

Prague, Czechia, 15006

Actively Recruiting

7

Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant

Lyon, France, 69677

Actively Recruiting

8

University Children's Hospital

Strasbourg, France, 67098

Actively Recruiting

9

Department of Medicine I (Nephrology), University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

10

University Children's Hospital

Berlin, Germany, 10117

Active, Not Recruiting

11

University Children's Hospital

Cologne, Germany, 50931

Actively Recruiting

12

University Children's Hospital

Essen, Germany, 45122

Actively Recruiting

13

UKE, University Children´s Hospital

Hamburg, Germany, 20251

Actively Recruiting

14

KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg

Marburg, Germany, 35043

Actively Recruiting

15

University Children's Hospital

Budapest, Hungary, 1083

Actively Recruiting

16

University Children'Hospital

Genova, Italy, 16147

Active, Not Recruiting

17

University Children's Hospital

Milan, Italy, 20122

Actively Recruiting

18

Pediatric Nephrology, Dialysis and Transplant Unit

Padova, Italy, 35128

Active, Not Recruiting

19

University children's Hospital

Vilnius, Lithuania, 08406

Actively Recruiting

20

Paediatric CAPD unit, Kuala Lumpur Hospital

Kuala Lumpur, Malaysia, 50586

Active, Not Recruiting

21

Krakow, Jagiellonian University Medical College

Krakow, Poland, 30663

Actively Recruiting

22

Hospital Universitario Materno-Infantil Vall d' Hebron

Barcelona, Spain, 08035

Actively Recruiting

23

Karolinska University Hospital

Stockholm, Sweden, 17176

Active, Not Recruiting

24

Children's Hospital, Inselspital, Bern University Hospital and University of Bern

Bern, Switzerland, 3010

Active, Not Recruiting

25

University Children's Hospital

Adana, Turkey (Türkiye), 01330

Actively Recruiting

26

Cerrahpasa School of Medicine

Istanbul, Turkey (Türkiye), 34303

Active, Not Recruiting

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Research Team

C

Claus P Schmitt, Prof

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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