Chronic Renal FailurePD-IDEANCT02470598
PD-Improved Dialysis Efficiency With Adapted APD
An observational study of Chronic Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 50 sites in 6 countries.
Trial summary
The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- Treatment with Adapted Automated Peritoneal Dialysis (aAPD)
- How many people
- 182 participants
- Where
- 50 sitesin 6 countries
- Study dates
- Mar 2015to 30 Jun 2020
- Phase
- Observational
- 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
Study population: Patients with chronic kidney disease (CKD) being treated or starting renal replacement therapy with aAPD
Who may be able to join
- CKD patients with indication for renal replacement therapy
- Patient treated or to be treated with aAPD
- Fluid status regularly monitored with BCM
Who cannot join
- Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg)
- Participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on PD solutions, studies on diuretics)
Trial locations and contacts
50 sites in 6 countries.
50 sites in 6 countries
Spain24 sites
Complejo Hospitalario universitario de Albacete
Albacete
Fundación Hospital de Alcorcón
Alcorcón
Complejo Asistencial de Avila
Ávila
Fundacion Puigvert
Barcelona
Hospital Clinic de Barcelona
Barcelona
Hospital de Basurto
Bilbao
Hospital General de Castellón
Castellon
Hospital Universitario di Girona Josep Trueta
Girona
Hospital General Virgen de las Nieves
Granada
Complejo hospitalario de Jaén
Jaén
Complejo Hospitalario San Millán-San Pedro De La Rioja
Logroño
Hospital Universitario Lucus Agusti
Lugo
Hospital Clínico San Carlos
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Hospital Carlos Haya
Málaga
Complexo Hospitalario Universitario de Ourense (CHUO)
Ourense
Hospital Universitario Central de Asturias (HUCA)
Oviedo
Hospital Universitatio Donostia
San Sebastián
Complejo Hospital Universitario de Santiago (CHUS)
Santiago de Compostela
Hospital Clínico de Valencia
Valencia
Hospital Peset
Valencia
Hospital Universitari i Politècnic La Fe
Valencia
Hospital Txagorritxu
Vitoria-Gasteiz
Czechia10 sites
Faculty Hospital Brno-Bohunice
Brno
Hospital Liberec
Liberec
Regional Hospital in Mlada Boleslav
Mladá Boleslav
Hospital Nove Mesto na Morave
Nové Město na Moravě
Faculty Hospital Pilsen
Pilsen
Faculty Hospital Karlovo namesti
Prague
Faculty Hospital Strahov
Prague
NC centre Vinohrady
Prague
NC centre Sokolov
Sokolov
Hospital Trebic
Třebíč
Sweden7 sites
Danderyds Sjukhus AB
Danderyd
Höglandssjukhuset Eksjö/Nässjö
Eksjö
Kalmar Hospital
Kalmar
Skåne University Hospital
Lund
Länssjukhuset Sundsvall
Sundsvall
Norra Älvsborgs Länssjukhus
Trollhättan
Norrlands University Hopsital
Umeå
Malaysia5 sites
Hospital Selayang
Batu Caves
Gleneagles Hospital Kuala Lumpur (GHKL)
Kuala Lumpur
Hospital Universiti Kebangsaan Malaysia (HUKM)
Kuala Lumpur
Hospital Serdang
Serdang
Hospital Seremban
Seremban
Finland3 sites
Helsinki University Hospital
Helsinki
Kymenlaakso Central Hospital
Kotka
Regional Hospital Roskilde
Lappeenranta
About this study
Official title: PD-Improved Dialysis Efficiency With Adapted APD - PD-IDEA
The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period.
Read the detailed description
In some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of APD. However, these studies have been performed in a small number of patients during a short observation period.
The aim of this study is to assess the hydration status of PD patients treated with aAPD and observe its development during one year using the BCM-Body Composition Monitor (BCM), a bioimpedance spectroscopy (BIS) device. In addition, it is intended to observe the variability of aAPD prescriptions and their influence on the hydration status of the patients.
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.
- Conditions
- Chronic Renal Failure
- Being tested
- Treatment with Adapted Automated Peritoneal Dialysis (aAPD)
- Keywords
- Automated Peritoneal Dialysis, Adapted APD (aAPD), Hydration status, Residual Renal Function, Ultrafiltration
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Adapted Automated Peritoneal Dialysis (aAPD)Other
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydration status
Assessed via body composition measurements
Measured: Every three months during one year
Secondary outcomes (4)
Residual renal function
Measured: Every three months during one year
Changes in prescription
Measured: Every three months during one year
Achievement of adequate solute removal
Measured: Every three months during one year
Therapy tolerability
Measured: Every three months during one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startMar 2015
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michel Fischbach, Prof., Study director, University Hospital HautepierreManel Vera, Dr., Study director, Hospital Clinic i Provinvial de BarcelonaEmilio Galli, Dr., Study director, Ospedale "Treviglio-Caravaggio" di TreviglioCecile Courivaud, Dr., Study director, University Hospotal BesanconVirpi Rauta, Dr., Study director, Helsinki Univerity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470598
- Sponsor's protocol ID
- PD-aAPD-01-INT
- Acronym
- PD-IDEA
- Status last verified
- Jul 2020
- First submitted
- 28 Apr 2015
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PD-Improved Dialysis Efficiency With Adapted APD - PD-IDEA
- ClinicalTrials.gov ID
- NCT02470598
- Acronym / sponsor ID
- PD-IDEA / PD-aAPD-01-INT
- Conditions
- Chronic Renal Failure
- Keywords
- Automated Peritoneal Dialysis, Adapted APD (aAPD), Hydration status, Residual Renal Function, Ultrafiltration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Jun 2015 (estimated)
- 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 aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period.
Detailed description
In some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of APD. However, these studies have been performed in a small number of patients during a short observation period.
The aim of this study is to assess the hydration status of PD patients treated with aAPD and observe its development during one year using the BCM-Body Composition Monitor (BCM), a bioimpedance spectroscopy (BIS) device. In addition, it is intended to observe the variability of aAPD prescriptions and their influence on the hydration status of the patients.
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease (CKD) being treated or starting renal replacement therapy with aAPD
Key inclusion criteria (3 listed)
- CKD patients with indication for renal replacement therapy
- Patient treated or to be treated with aAPD
- Fluid status regularly monitored with BCM
Key exclusion criteria (2 listed)
- Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg)
- Participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on PD solutions, studies on diuretics)
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 |
|---|---|---|
| Treatment with Adapted Automated Peritoneal Dialysis (aAPD)This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists | Other | – |
Primary outcome
Hydration status
Time frame: Every three months during one year
Assessed via body composition measurements
4 secondary outcomes
Residual renal function
Time frame: Every three months during one year
Changes in prescription
Time frame: Every three months during one year
Achievement of adequate solute removal
Time frame: Every three months during one year
Therapy tolerability
Time frame: Every three months during one year
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 6 Aug 2020.
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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.
Michel Fischbach, Prof. study director
University Hospital Hautepierre
Manel Vera, Dr. study director
Hospital Clinic i Provinvial de Barcelona
Emilio Galli, Dr. study director
Ospedale "Treviglio-Caravaggio" di Treviglio
50 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 50 sites in 6 countries.
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 3 inclusion and 2 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 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Spain, Czechia, Sweden, Malaysia, Finland and 1 more country. 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?
Hydration status (time frame: Every three months during one year). 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 6 Aug 2020.