International (Pediatric) Peritoneal Biobank

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Heidelberg University
Study ID
NCT01893710
Status
Recruiting
Apply to this trial

Conditions

  • Healthy
  • Kidney Failure, Chronic
  • Peritoneal Dialysis Complication
  • Transplantation

Eligibility Criteria

Sex
ALL
Age
1 Day - 90 Years
Healthy Volunteers
Accepted

Interventions

  • biopsy sampling — PROCEDURE
    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 Details

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.

Key Dates

Start date
Feb 1, 2011
Status verified
Dec 2024
Primary completion
Oct 1, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 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.
  • Arm: chronic kidney disease
    Samples will obtained from patients with chronic kidney disease stage 5 (at time of catheter Insertion)
  • Arm: Peritoneal dialysis
    Patients on PD with different PD fluids and intercurrent abdominal surgery and at time of renal transplantation.
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Children's Mercy HospitalKansas CityMissouri64108
Bradley A. Warady, MD
[email protected]
+1 8162343010
Bradley A. Warady, MD (PRINCIPAL_INVESTIGATOR)
The Children´s Hospital of PhiladelphiaNarberthPennsylvania19104-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALChildren's Mercy Hospital· Kansas City, MOThe Children´s Hospital of Philadelphia· Narberth, PA

Related Studies