An observational study in Renal Insufficiency / Therapy, sponsored by Fresenius Medical Care Deutschland GmbH. Recruiting at 2 sites in Germany. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Fresenius Medical Care Deutschland GmbH (part of Fresenius Medical Care) · Observational
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.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's planned enrollment of 300 is above the median of 178 across 292 observational studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Safety variables
Catheter related infections (e.g. peritonitis, tunnel infections, exit site infection)
Time frame: Every 6 months (± 2 months, as per centre practice)
Safety variables
Non-infectious complications
Time frame: Every 6 months (± 2 months, as per centre practice)
Safety variables
Biocompatibility (allergic reaction)
Time frame: Every 6 months (± 2 months, as per centre practice)
Safety variables
Identify new emerging risks
Time frame: Every 6 months (± 2 months, as per centre practice)
Safety variables
Monitor side effects
Time frame: Every 6 months (± 2 months, as per centre practice)
Safety variables
Catheter removal
Time frame: Every 6 months (± 2 months, as per centre practice)
Performance variables
Catheter patency
Time frame: very 6 months (± 2 months, as per centre practice)
Performance variables
Non-infectious complication
Time frame: very 6 months (± 2 months, as per centre practice)
Outcome variables
Peritoneal clearance
Time frame: very 6 months (± 2 months, as per centre practice)
Outcome variables
Peritoneal UF
Time frame: very 6 months (± 2 months, as per centre practice)
Outcome variables
Mechanical complications
Time frame: very 6 months (± 2 months, as per centre practice)
Outcome variables
Therapy tolerability.
Time frame: very 6 months (± 2 months, as per centre practice)
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