Kidney Failure, ChronicNCT01893710
International (Pediatric) Peritoneal Biobank
An observational study of Kidney Failure, Chronic and Peritoneal Dialysis Complication, run by Heidelberg University at 26 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure, Chronic, Peritoneal Dialysis Complication, Transplantation
- What is being tested?
- biopsy sampling
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 26 sitesin 15 countries
- Study dates
- 1 Feb 2011to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: See eligibility data
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 15 countries
Germany6 sites, 5 recruiting
- Active, not recruiting
University Children's Hospital
Berlin, 10117
- Recruiting
University Children's Hospital
Cologne, 50931
Christina Taylan, MD, +49 2214784391, christina.taylan@uk-koeln.de
Christina Taylan, MD
- Recruiting
University Children's Hospital
Essen, 45122
Rainer Büscher, MD, +49 201 723-2738, Rainer.Buescher@uk-essen.de
Rainer Büscher, MD
- Recruiting
UKE, University Children´s Hospital
Hamburg, 20251
Jun Oh, MD, +49 40 7410 0, j.oh@uke.de
Christian Brix, MD
- Recruiting
Department of Medicine I (Nephrology), University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Katrin Klein, MD, +49 62215639776, katrin.klein@med.uni-heidelberg.de
- Recruiting
KfH Pediatric Kidney Center, Department of Pediatric Nephrology, University of Marburg
Marburg, 35043
Günter Klaus, Prof, +49 64215862254, Guenter.Klaus@kfh-dialyse.de
United States3 sites, 1 recruiting
- Active, not recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Bradley A. Warady, MD, +1 8162343010, bwarady@cmh.edu
Bradley A. Warady, MD
- Active, not recruiting
The Children´s Hospital of Philadelphia
Narberth, Pennsylvania, 19104
Italy3 sites, 1 recruiting
- Active, not recruiting
University Children'Hospital
Genova, 16147
- Recruiting
University Children's Hospital
Milan, 20122
Sara Testa, MD, +39 0257992471, saratesta@tiscali.it
Sara Testa, MD
- Active, not recruiting
Pediatric Nephrology, Dialysis and Transplant Unit
Padova, 35128
France2 sites, 2 recruiting
- Recruiting
Service de Néphrologie Pédiatrique, Hôpital Femme Mere Enfant
Lyon, 69677
Bruno Ranchin, MD, +33 427856129, bruno.ranchin@chu-lyon.fr
Bruno Ranchin, MD
- Recruiting
University Children's Hospital
Strasbourg, 67098
Ariane Zaloszyc, MD, +333388127742, ariane.zaloszyc@chru-strasbourg.fr
Ariane Zaloszyc, MD
Turkey (Türkiye)2 sites, 1 recruiting
- Recruiting
University Children's Hospital
Adana, 01330
Aysun K Bayazit, MD, +90 3223386935, ayskar@cu.edu.tr
Aysun K Bayazit, MD
- Active, not recruiting
Cerrahpasa School of Medicine
Istanbul, 34303
Austria1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Medical University Vienna
Vienna, 1090
Klaus Arbeiter, MD, +43 1404003257, klaus.arbeiter@meduniwien.ac.at
Klaus Arbeiter, MD
Belgium1 site, 1 recruiting
- Recruiting
UZ Ghent
Ghent, 9890
Johan Van de Walle, MD, +32 93322483, Johan.VandeWalle@uzgent.be
Johan Van de Walle, MD
Czechia1 site, 1 recruiting
- Recruiting
University Children's Hospital
Prague, 15006
Karel Vondrak, MD, +42 0224432078, 8080@seznam.cz
Karel Vondrak, MD
Hungary1 site, 1 recruiting
- Recruiting
University Children's Hospital
Budapest, 1083
Peter Sallay, MD, +36 13343186, sallay.peter@med.semmelweis-univ.hu
Peter Sallay, MD
Lithuania1 site, 1 recruiting
- Recruiting
University children's Hospital
Vilnius, 08406
Rimante Cerkauskiene, MD, +37 052720427, rimantec@yahoo.com
Rimante Cerkauskiene, MD
Malaysia1 site
- Active, not recruiting
Paediatric CAPD unit, Kuala Lumpur Hospital
Kuala Lumpur, 50586
Poland1 site, 1 recruiting
- Recruiting
Krakow, Jagiellonian University Medical College
Krakow, 30663
Dorota Drozdz, MD, +48 12 658 11 59, dadrozdz@cm-uj.krakow.pl
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Materno-Infantil Vall d' Hebron
Barcelona, 08035
Gema Ariceta, MD, +34 934893082, gariceta@vhebron.net
Gema Ariceta, MD
Sweden1 site
- Active, not recruiting
Karolinska University Hospital
Stockholm, 17176
Switzerland1 site
- Active, not recruiting
Children's Hospital, Inselspital, Bern University Hospital and University of Bern
Bern, 3010
About this study
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.
Read the detailed description
Please see study protocol and
http://www.pedpd.org
- Being tested
- biopsy sampling
- Keywords
- peritoneal dialysis, parietal peritoneum, omentum, chronic kidney disease, vasculopathy
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy samplingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: biopsy sampling | |
| Peritoneal dialysis | Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation. Receives: Procedure: biopsy sampling | |
| 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. Receives: Procedure: biopsy sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal vasculopathy (lumen vessel ratio)
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)
Measured: Two years (Mean PD treatment time)
Secondary outcomes (1)
Number of vessels per peritoneal membrane area (per mm²)
Digital histomorphometry of small vessel density per mm² submesothelial section area analysed.
Measured: at time of catheter insertion, intercurrent abdominal surgery and at time of renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study start1 Feb 2011
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claus Peter Schmitt, Heidelberg University
- Investigators
- Claus P Schmitt, MD, Principal investigator, University of Heidelberg, Center for Pediatric and Adolescent Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893710
- Sponsor's protocol ID
- IPPB Biobank
- Other IDs
- University of Heidelberg
- Status last verified
- Dec 2024
- First submitted
- 27 Jun 2013
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Levai E, Marinovic I, Bartosova M, Zhang C, Schaefer B, Jenei H, Du Z, Drozdz D, Klaus G, Arbeiter K, Romero P, Schwenger V, Schwab C, Szabo AJ, Zarogiannis SG, Schmitt CP. Human peritoneal tight junction, transporter and channel expression in health and kidney failure, and associated solute transport. Sci Rep. 2023 Oct 13;13(1):17429. doi: 10.1038/s41598-023-44466-z.
PubMed 37833387Catar RA, Bartosova M, Kawka E, Chen L, Marinovic I, Zhang C, Zhao H, Wu D, Zickler D, Stadnik H, Karczewski M, Kamhieh-Milz J, Jorres A, Moll G, Schmitt CP, Witowski J. Angiogenic Role of Mesothelium-Derived Chemokine CXCL1 During Unfavorable Peritoneal Tissue Remodeling in Patients Receiving Peritoneal Dialysis as Renal Replacement Therapy. Front Immunol. 2022 Feb 4;13:821681. doi: 10.3389/fimmu.2022.821681. eCollection 2022.
PubMed 35185912Bartosova M, Zhang C, Schaefer B, Herzog R, Ridinger D, Damgov I, Levai E, Marinovic I, Eckert C, Romero P, Sallay P, Ujszaszi A, Unterwurzacher M, Wagner A, Hildenbrand G, Warady BA, Schaefer F, Zarogiannis SG, Kratochwill K, Schmitt CP. Glucose Derivative Induced Vasculopathy in Children on Chronic Peritoneal Dialysis. Circ Res. 2021 Aug 20;129(5):e102-e118. doi: 10.1161/CIRCRESAHA.121.319310. Epub 2021 Jul 8.
PubMed 34233458
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International (Pediatric) Peritoneal Biobank
- ClinicalTrials.gov ID
- NCT01893710
- Acronym / sponsor ID
- IPPB Biobank
- Keywords
- peritoneal dialysis, parietal peritoneum, omentum, chronic kidney disease, vasculopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please see study protocol and
http://www.pedpd.org
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: biopsy samplingSamples will obtained from patients with chronic kidney disease stage 5 (at time of catheter Insertion) |
| Peritoneal dialysis | – | Procedure: biopsy samplingPatients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation. |
| Post PD and with functioning graft | – | Procedure: biopsy samplingSamples 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. |
Who may qualify
- Ages
- 1 day to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- See eligibility data
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy samplingTwo 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. | Procedure or surgery | Peritoneal dialysis, Post PD and with functioning graft, chronic kidney disease |
Primary outcome
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)
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Derived from this study: PubMed 37833387Levai E, Marinovic I, Bartosova M, Zhang C, Schaefer B, Jenei H, Du Z, Drozdz D, Klaus G, Arbeiter K, Romero P, Schwenger V, Schwab C, Szabo AJ, Zarogiannis SG, Schmitt CP. Human peritoneal tight junction, transporter and channel expression in health and kidney failure, and associated solute transport. Sci Rep. 2023 Oct 13;13(1):17429. doi: 10.1038/s41598-023-44466-z.
- Derived from this study: PubMed 35185912Catar RA, Bartosova M, Kawka E, Chen L, Marinovic I, Zhang C, Zhao H, Wu D, Zickler D, Stadnik H, Karczewski M, Kamhieh-Milz J, Jorres A, Moll G, Schmitt CP, Witowski J. Angiogenic Role of Mesothelium-Derived Chemokine CXCL1 During Unfavorable Peritoneal Tissue Remodeling in Patients Receiving Peritoneal Dialysis as Renal Replacement Therapy. Front Immunol. 2022 Feb 4;13:821681. doi: 10.3389/fimmu.2022.821681. eCollection 2022.
- Derived from this study: PubMed 34233458Bartosova M, Zhang C, Schaefer B, Herzog R, Ridinger D, Damgov I, Levai E, Marinovic I, Eckert C, Romero P, Sallay P, Ujszaszi A, Unterwurzacher M, Wagner A, Hildenbrand G, Warady BA, Schaefer F, Zarogiannis SG, Kratochwill K, Schmitt CP. Glucose Derivative Induced Vasculopathy in Children on Chronic Peritoneal Dialysis. Circ Res. 2021 Aug 20;129(5):e102-e118. doi: 10.1161/CIRCRESAHA.121.319310. Epub 2021 Jul 8.
- International Pediatric Peritoneal Dialysis NetworkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claus P Schmitt, MD principal investigator
University of Heidelberg, Center for Pediatric and Adolescent Medicine
26 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Peritoneal Dialysis Complication, run by Heidelberg University at 26 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, United States, Italy, France, Turkey (Türkiye) and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claus P Schmitt, Prof (+49 6221 56 ext. 39313, claus.peter.schmitt@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal vasculopathy (lumen vessel ratio) (time frame: Two years (Mean PD treatment time)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893710, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.