Renal Insufficiency / TherapyCatheterNCT07156123
PD Catheter Data Collection
An observational study of Renal Insufficiency / Therapy, run by Fresenius Medical Care Deutschland GmbH at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Insufficiency / Therapy
- How many people
- 300 participants
- Where
- 2 sitesGermany
- Study dates
- 3 Jul 2026to Dec 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Dortmund gGmbH
Dortmund, 44137
Fedai Özcan, Dr. med., Fedai.oezcan@klinikumdo.de
- Recruiting
RCU- Renal Care Unit, Dr. med. Mario Gerrit Bohling
Wilhelmshaven, 26389
Mario Gerrit Bohling, Dr. med., mario.bohling@googlemail.com
About this study
Official title: Analysis of Safety and Efficacy of Long-term Treatment With PD Catheters
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
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables
Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)
Measured: Every 6 months (± 2 months, as per centre practice)
Safety variables
Non-infectious complications
Measured: Every 6 months (± 2 months, as per centre practice)
Safety variables
Biocompatibility (allergic reaction)
Measured: Every 6 months (± 2 months, as per centre practice)
Safety variables
Identify new emerging risks
Measured: Every 6 months (± 2 months, as per centre practice)
Safety variables
Monitor side effects
Measured: Every 6 months (± 2 months, as per centre practice)
Safety variables
Catheter removal
Measured: Every 6 months (± 2 months, as per centre practice)
Secondary outcomes (6)
Performance variables
Catheter patency
Measured: very 6 months (± 2 months, as per centre practice)
Performance variables
Non-infectious complication
Measured: very 6 months (± 2 months, as per centre practice)
Outcome variables
Peritoneal clearance
Measured: very 6 months (± 2 months, as per centre practice)
Outcome variables
Peritoneal UF
Measured: very 6 months (± 2 months, as per centre practice)
Outcome variables
Mechanical complications
Measured: very 6 months (± 2 months, as per centre practice)
Outcome variables
Therapy tolerability.
Measured: very 6 months (± 2 months, as per centre practice)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start3 Jul 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency / TherapyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fedai Özcan, Dr. med., Principal investigator, Klinikum Dortmund Wirbelsäulenchirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156123
- Sponsor's protocol ID
- PD-Cathether-01-INT
- Acronym
- Catheter
- Status last verified
- Sep 2026
- First submitted
- 21 May 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Safety and Efficacy of Long-term Treatment With PD Catheters
- ClinicalTrials.gov ID
- NCT07156123
- Acronym / sponsor ID
- Catheter / PD-Cathether-01-INT
- Conditions
- Renal Insufficiency / Therapy
- Keywords
- Peritoneal dialysis, Renal replacement therapy, Ultrafiltration, Catheter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Sep 2025 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety variables
Time frame: Every 6 months (± 2 months, as per centre practice)
Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)
Safety variables
Time frame: Every 6 months (± 2 months, as per centre practice)
Non-infectious complications
Safety variables
Time frame: Every 6 months (± 2 months, as per centre practice)
Biocompatibility (allergic reaction)
Safety variables
Time frame: Every 6 months (± 2 months, as per centre practice)
Identify new emerging risks
Safety variables
Time frame: Every 6 months (± 2 months, as per centre practice)
Monitor side effects
Safety variables
Time frame: Every 6 months (± 2 months, as per centre practice)
Catheter removal
6 secondary outcomes
Performance variables
Time frame: very 6 months (± 2 months, as per centre practice)
Performance variables
Time frame: very 6 months (± 2 months, as per centre practice)
Outcome variables
Time frame: very 6 months (± 2 months, as per centre practice)
Outcome variables
Time frame: very 6 months (± 2 months, as per centre practice)
Outcome variables
Time frame: very 6 months (± 2 months, as per centre practice)
Outcome variables
Time frame: very 6 months (± 2 months, as per centre practice)
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 8 Sep 2026.
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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.
Fedai Özcan, Dr. med. principal investigator
Klinikum Dortmund Wirbelsäulenchirurgie
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Insufficiency / Therapy, run by Fresenius Medical Care Deutschland GmbH at 2 sites in Germany.
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 7 inclusion and 3 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Fiona Bellando (+49 6172 8868776, fiona.bellando@freseniusmedicalcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety variables (time frame: Every 6 months (± 2 months, as per centre practice)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.