Actively Recruiting

Age: 1Day - 90Years
All Genders
Healthy Volunteers
ID01893710

International (Pediatric) Peritoneal Biobank for Kidney Failure and Peritoneal Dialysis Complications

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

500

Participants Needed

26

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the changes in the peritoneal membrane of children and adults undergoing peritoneal dialysis (PD), focusing on early tissue and vascular changes that occur during treatment. The study aims to understand how the membrane transforms over time, leading to complications such as fibrosis, blood vessel changes, and loss of membrane function, which can cause PD to fail. This international, prospective study includes children with kidney failure and those receiving PD, as well as healthy individuals undergoing abdominal surgery for comparison. The study involves collecting peritoneal membrane biopsies during clinically required surgeries, such as catheter insertion, hernia repair, catheter exchange, and kidney transplantation. Biopsies and tissue samples are analyzed using detailed histomorphometry and protein expression to relate structural changes to PD treatment types, duration, and functional outcomes. Blood samples are taken during routine clinical care to study inflammation and cardiovascular markers. The study also includes patients after kidney transplantation to evaluate the membrane's response post-PD. Participants will undergo surgery for clinical reasons where tissue samples are collected without significantly increasing surgical time or risk. Researchers will measure vessel changes in the peritoneal membrane and correlate findings with PD treatment time and other health factors. The study tracks these changes over several years, with the main outcome being the degree of blood vessel disease in the membrane after two years of PD treatment. Overall, the study may provide insights to optimize PD treatment based on individual membrane characteristics.

CONDITIONS

Brief 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 5 or receiving peritoneal dialysis
  • Patients with normal kidney function undergoing elective abdominal surgery for limited conditions like hernia repair or gallstones
  • Patients after peritoneal dialysis and 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 inflammation beyond changes caused by peritoneal dialysis
  • Diagnosis of disseminated tumor disease
  • Critical heart failure or other medical conditions increasing surgical risk
  • Pregnancy
  • Preterm babies born before 37 weeks gestational age
  • Low serum hemoglobin: less than 10 g/dl in newborns and less than 8 g/dl in children and adults

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Occurs at the time of clinical procedures

Participants undergo biopsy sampling during routine abdominal surgeries or catheter procedures for tissue analysis.

1 to 3 visits depending on surgery or catheter removal timing

Long-term Monitoring

Duration - Up to 2 years

Participants are followed to observe peritoneal and kidney health over time after biopsy sampling.

Follow-up visits as part of routine care

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

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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Published Research Related To This Trial

Human peritoneal tight junction, transporter and channel expression in health and kidney failure, and associated solute transport.

Eszter Levai, Iva Marinovic, Maria Bartosova...

https://pubmed.ncbi.nlm.nih.gov/37833387

Angiogenic Role of Mesothelium-Derived Chemokine CXCL1 During Unfavorable Peritoneal Tissue Remodeling in Patients Receiving Peritoneal Dialysis as Renal Replacement Therapy.

Rusan Ali Catar, Maria Bartosova, Edyta Kawka...

https://pubmed.ncbi.nlm.nih.gov/35185912