Renal FailureNCT04749680
Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
A study testing PD cycler Silencia in people with Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 4 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, End Stage Renal Disease
- What is being tested?
- PD cycler Silencia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 4 sitesChile
- Study dates
- 31 May 2021to 12 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Chile4 sites
Nephocare La Serena
La Serena
Nephocare Independencia
Santiago
Nephocare Providencia
Santiago
Nephocare San Bernardo
Santiago
About this study
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.
- Conditions
- Renal Failure, End Stage Renal Disease
- Being tested
- PD cycler Silencia
- Keywords
- Peritoneal dialysis, Automated peritoneal dialysis (APD), PD cyler, Renal replacement therapy
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD cycler SilenciaDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal dialysis PD | Experimental | 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). Receives: Device: PD cycler Silencia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Kt/V urea
Measurement of solute removal during peritoneal dialysis focuses on urea
Measured: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Achieving Kt/Vurea ≥ 1.7
Measurement of solute removal during peritoneal dialysis focuses on urea
Measured: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Mean daily ultrafiltration (UF)
Daily ultrafiltration reached by the Patient with APD
Measured: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start31 May 2021
- Primary completion12 Oct 2021
- Study completion12 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Prospective, controlled, multicentre, interventional
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH, James Motta, Clinical Research Associate (CRA)
- Responsible party
- Sponsor
- Investigators
- Eduardo Machuca, Dr, Principal investigator, Fresenius Medical Care Chile S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749680
- Sponsor's protocol ID
- PD-Silencia-01-CL
- Status last verified
- Aug 2022
- First submitted
- 26 Jan 2021
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Tolerability of APD Treatment With Different PD Cyclers
- ClinicalTrials.gov ID
- NCT04749680
- Acronym / sponsor ID
- PD-Silencia-01-CL
- Conditions
- Renal Failure, End Stage Renal Disease
- Keywords
- Peritoneal dialysis, Automated peritoneal dialysis (APD), PD cyler, Renal replacement therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Winicker Norimed GmbH, James Motta, Clinical Research Associate (CRA)
- Study start
- 31 May 2021 (actual)
- Primary completion
- 12 Oct 2021 (actual)
- Study completion
- 12 Oct 2021 (actual)
- First posted
- 11 Feb 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, controlled, multicentre, interventional
| Arm | Type | Receives |
|---|---|---|
| Peritoneal dialysis PD | Experimental | Device: PD cycler SilenciaTreatment 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD cycler SilenciaTreatment 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). | Device | Peritoneal dialysis PD |
Primary outcome
Total Kt/V urea
Time frame: 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
Time frame: 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)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Eduardo Machuca, Dr principal investigator
Fresenius Medical Care Chile S.A.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PD cycler Silencia in people with Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 4 sites in Chile.
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 9 inclusion and 8 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: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Kt/V urea (time frame: at the beginning and end of clinical phase 1 and 2 (each clinical phase is 14 days)). The study lists 3 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 2 Aug 2022.