Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers

Sponsor

Fresenius Medical Care Deutschland GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT04749680

Collaborator

Winicker Norimed GmbH (Industry), James Motta, Clinical Research Associate (CRA) (Other)

Enrollment

Locations

Arm

4.4

Actual Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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 which are both well-established PD cyclers.

Condition or Disease	Intervention/Treatment	Phase
Renal Failure End Stage Renal Disease	Device: PD cycler Silencia	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Intervention Model Description:

Prospective, controlled, multicentre, interventionalProspective, controlled, multicentre, interventional

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers

Actual Study Start Date :

May 31, 2021

Actual Primary Completion Date :

Oct 12, 2021

Actual Study Completion Date :

Oct 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Peritoneal dialysis PD Treatment for 2 weeks either with the comparators PD-Night or Homechoice PD cycler depending on the previous treatment (clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).	Device: PD cycler Silencia Treatment for 2 weeks either with PD-Night or Homechoice PD cycler (Comparators) depending on the previous Treatment ((clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).

Arm

Intervention/Treatment

Experimental: Peritoneal dialysis PD

Treatment for 2 weeks either with the comparators PD-Night or Homechoice PD cycler depending on the previous treatment (clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).

Device: PD cycler Silencia

Treatment for 2 weeks either with PD-Night or Homechoice PD cycler (Comparators) depending on the previous Treatment ((clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).

Outcome Measures

Primary Outcome Measures

Total Kt/V urea [at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)]
Measurement of solute removal during peritoneal dialysis focuses on urea
Achieving Kt/Vurea ≥ 1.7 [at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)]
Measurement of solute removal during peritoneal dialysis focuses on urea
Mean daily ultrafiltration (UF) [at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)]
Daily ultrafiltration reached by the Patient with APD

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Locations

	Site	City	Country
1	Nephocare La Serena	La Serena	Chile
2	Nephocare Independencia	Santiago	Chile
3	Nephocare Providencia	Santiago	Chile
4	Nephocare San Bernardo	Santiago	Chile

Sponsors and Collaborators

Fresenius Medical Care Deutschland GmbH
Winicker Norimed GmbH
James Motta, Clinical Research Associate (CRA)

Investigators

Principal Investigator: Eduardo Machuca, Dr, Fresenius Medical Care Chile S.A.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fresenius Medical Care Deutschland GmbH

ClinicalTrials.gov Identifier:

NCT04749680

Other Study ID Numbers:

PD-Silencia-01-CL

First Posted:

Feb 11, 2021

Last Update Posted:

Aug 2, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fresenius Medical Care Deutschland GmbH

Peritoneal dialysis

Automated peritoneal dialysis (APD)

PD cyler

Renal replacement therapy

Additional relevant MeSH terms:

Kidney Failure, Chronic

Study Results

No Results Posted as of Aug 2, 2022