Recruiting

Observational Study

Sponsor:

Heidelberg University

Code:

NCT01893710

Conditions

Kidney Failure, Chronic

Peritoneal Dialysis Complication

Transplantation

Healthy

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

biopsy sampling

Study Details

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.

Conditions

Kidney Failure, Chronic

Peritoneal Dialysis Complication

Transplantation

Healthy

Study ID

NCT01893710

Start date

Feb 1, 2011

Status verified date

Dec, 2024

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Peritoneal dialysis

Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.

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.

Interventions

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 measure

  • Peritoneal vasculopathy (lumen vessel ratio) [ Time Frame: Two years (Mean PD treatment time) ]

Central Contacts and Locations

Central contacts

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Bradley A. Warady, MD

+1 8162343010bwarady@cmh.edu

Principal Investigator:

Bradley A. Warady, MD

More Information

Sponsor

Heidelberg University

Last update posted

Apr 30, 2026

Last verified

Dec, 2024

Keywords

  • peritoneal dialysis
  • parietal peritoneum
  • omentum
  • chronic kidney disease
  • vasculopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Heidelberg University on 2026-04-30.