PD Catheter Data Collection

NCT07156123 | Not Yet Recruiting

• 1 other identifier: PD-Cathether-01-INT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Peritoneal Dialysis (PD) is a Renal Replacement Therapy for patients with renal insufficiency that has been used more frequently in recent years. In PD treatment, catheter are used to provide access to the peritoneal cavity, allowing the dialysate to be introduced and removed from the abdomen. The aim of this study is to evaluate the safety and efficacy of long-term treatment with PD catheters (developed by Fresenius Medical Care (FME)) in adult and paediatric patients treated with CAPD or APD. Safety and performance parameters of the catheters will be analyzed, as well as data on PD treatment outcome, such as Peritoneal Clearance and Peritoneal Ultrafiltration.

Conditions

Renal Insufficiency / Therapy

Keywords

Peritoneal dialysis; Renal replacement therapy; Ultrafiltration; Catheter

Outcome Measures

Primary Outcomes (6)

• Safety variables

  Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)

  Every 6 months (± 2 months, as per centre practice)

• Safety variables

  Non-infectious complications

  Every 6 months (± 2 months, as per centre practice)

• Safety variables

  Biocompatibility (allergic reaction)

  Every 6 months (± 2 months, as per centre practice)

• Safety variables

  Identify new emerging risks

  Every 6 months (± 2 months, as per centre practice)

• Safety variables

  Monitor side effects

  Every 6 months (± 2 months, as per centre practice)

• Safety variables

  Catheter removal

  Every 6 months (± 2 months, as per centre practice)

Secondary Outcomes (6)

• Performance variables

  very 6 months (± 2 months, as per centre practice)

• Performance variables

  very 6 months (± 2 months, as per centre practice)

• Outcome variables

  very 6 months (± 2 months, as per centre practice)

• Outcome variables

  very 6 months (± 2 months, as per centre practice)

• Outcome variables

  very 6 months (± 2 months, as per centre practice)

Study Arms (1)

PD treatment

Include all the patients treated with peritoneal dialysis (PD or APD) using the PD catheter as described and who who will begin PD, or patients who began PD within the last 1.5 years before start of the study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients treated with peritoneal dialysis (PD or APD) using the PD catheter as described and who who will begin PD, or patients who began PD within the last 1.5 years before start of the study

You may qualify if:

• Signed and dated informed consent for study participation and data submission (by the patient or legal representative for patients under 18) along with investigator/authorized physician signature.
• Patients under 18 who have received age- and maturity-appropriate information per Article 63(2) MDR from trained investigators or team members; minors capable of understanding must also sign the informed consent.
• The investigator must respect the decision of any minor, capable of understanding the information as per Article 63(2) MDR, to decline participation or withdraw from the clinical investigation at any time.
• Ability to understand the nature and requirements of the study.
• Patients with indication for renal replacement therapy, specifically PD (CAPD or APD)
• Patients who began PD using FME catheters within the last 18 months and are either prevalent in PD at study initiation or have switched to HD or undergone transplantation and can consent to data use.
• Incident patients who will begin PD using FME catheters.

You may not qualify if:

• Patient or legal representative is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations,
• Previous participation in the same study.
• Life expectancy \< 3 months.

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (1)

Klinikum Dortmund gGmbH

Dortmund, 44137, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Fedai Özcan, Dr. med.

  Klinikum Dortmund Wirbelsäulenchirurgie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiona Bellando

CONTACT

+49 6172 8868776; fiona.bellando@freseniusmedicalcare.com

Celina Meyer

CONTACT

+49 6172 268 6809; celina.meyer@freseniusmedicalcare.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: September 4, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

DE (1)