Status:
COMPLETED
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Collaborating Sponsors:
Winicker Norimed GmbH
James Motta, Clinical Research Associate (CRA)
Conditions:
Renal Failure
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study has been designed in order to investigate the performance and safety of the new Silencia PD cycler including the Silencia tubing system in comparison to the PD-Night and Homechoice PD cycler...
Eligibility Criteria
Inclusion
- Informed consent signed and dated by study patient and investigator/authorised physician
- CKD patients being treated with APD for at least 3 months
- Minimum age of 18 years
- Body weight ≥ 40 kg
- Fluid status regularly monitored with Body Composition Monitor (BCM)
- Patients planned to change to the Silencia PD cycler
- Proper functioning catheter
- Intraperitoneal Pressure (IPP) ≤ 18 cm H2O for the maximum of TAVO parameter "permitted patient volume"
- Ability to understand the nature and requirements of the study
Exclusion
- Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
- Patients receiving polyglucose containing PD solution
- Any conditions which could interfere with the patient's ability to comply with the study
- Patients who suffer from peritonitis/exit site infection during the last 4 weeks
- Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
- Life expectancy \< 3 months
- Participation in an interventional clinical study during the preceding 30 days
- Previous participation in the same study
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04749680
Start Date
May 31 2021
End Date
October 12 2021
Last Update
August 2 2022
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Nephocare La Serena
La Serena, Chile
2
Nephocare Independencia
Santiago, Chile
3
Nephocare Providencia
Santiago, Chile
4
Nephocare San Bernardo
Santiago, Chile