PD-Improved Dialysis Efficiency With Adapted APD (PD-IDEA)

August 5, 2020 updated by: Fresenius Medical Care Deutschland GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • Faculty Hospital Brno-Bohunice
      • Liberec, Czechia
        • Hospital Liberec
      • Mlada Boleslav, Czechia
        • Regional Hospital in Mlada Boleslav
      • Nove Mesto na Morave, Czechia
        • Hospital Nové Město na Moravě
      • Pilsen, Czechia
        • Faculty Hospital Pilsen
      • Prague, Czechia
        • Faculty Hospital Karlovo namesti
      • Prague, Czechia
        • Faculty Hospital Strahov
      • Prague, Czechia
        • NC centre Vinohrady
      • Sokolov, Czechia
        • NC centre Sokolov
      • Trebic, Czechia
        • Hospital Třebíč
  • Denmark
      • Viborg, Denmark
        • Regional Hospital Viborg
  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
      • Kotka, Finland
        • Kymenlaakso Central Hospital
      • Lappeenranta, Finland
        • Regional Hospital Roskilde
  • Malaysia
      • Batu Caves, Malaysia
        • Hospital Selayang
      • Kuala Lumpur, Malaysia
        • Gleneagles Hospital Kuala Lumpur (GHKL)
      • Kuala Lumpur, Malaysia
        • Hospital Universiti Kebangsaan Malaysia (HUKM)
      • Serdang, Malaysia
        • Hospital Serdang
      • Seremban, Malaysia
        • Hospital Seremban
  • Spain
      • Albacete, Spain
        • Complejo Hospitalario Universitario de Albacete
      • Alcorcón, Spain
        • Fundacion Hospital de Alcorcon
      • Barcelona, Spain
        • Hospital Clinic de Barcelona
      • Barcelona, Spain
        • Fundacion Puigvert
      • Bilbao, Spain
        • Hospital de Basurto
      • Castellón De La Plana, Spain
        • Hospital General de Castellón
      • Girona, Spain
        • Hospital Universitario di Girona Josep Trueta
      • Granada, Spain
        • Hospital General Virgen de las Nieves
      • Jaén, Spain
        • Complejo Hospitalario de Jaén
      • Logroño, Spain
        • Complejo Hospitalario San Millán-San Pedro De La Rioja
      • Lugo, Spain
        • Hospital Universitario Lucus Agustí
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Majadahonda, Spain
        • Hospital Universitario Puerta de Hierro
      • Málaga, Spain
        • Hospital Carlos Haya
      • Ourense, Spain
        • Complexo Hospitalario Universitario de Ourense (CHUO)
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias (HUCA)
      • San Sebastián, Spain
        • Hospital Universitatio Donostia
      • Santiago De Compostela, Spain
        • Complejo Hospital Universitario de Santiago (CHUS)
      • Valencia, Spain
        • Hospital Clinico de Valencia
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain
        • Hospital Peset
      • Vitoria, Spain
        • Hospital Txagorritxu
      • Ávila, Spain
        • Complejo Asistencial de Ávila
  • Sweden
      • Danderyd, Sweden
        • Danderyds Sjukhus AB
      • Eksjö, Sweden
        • Höglandssjukhuset Eksjö/Nässjö
      • Kalmar, Sweden
        • Kalmar Hospital
      • Lund, Sweden
        • Skane University Hospital
      • Sundsvall, Sweden
        • Länssjukhuset Sundsvall
      • Trollhättan, Sweden
        • Norra Älvsborgs Länssjukhus
      • Umeå, Sweden
        • Norrlands University Hopsital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic kidney disease (CKD) being treated or starting renal replacement therapy with aAPD

Description

Inclusion Criteria:

  • CKD patients with indication for renal replacement therapy
  • Patient treated or to be treated with aAPD
  • Fluid status regularly monitored with BCM

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hydration status
Time Frame: Every three months during one year
Assessed via body composition measurements
Every three months during one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Residual renal function
Time Frame: Every three months during one year
Every three months during one year
Changes in prescription
Time Frame: Every three months during one year
Every three months during one year
Achievement of adequate solute removal
Time Frame: Every three months during one year
Every three months during one year
Therapy tolerability
Time Frame: Every three months during one year
Every three months during one year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change of therapy modality
Time Frame: Every three months during one year
Every three months during one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Medical Care Deutschland GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michel Fischbach, Prof., University Hospital Hautepierre
  • Study Director: Manel Vera, Dr., Hospital Clinic i Provinvial de Barcelona
  • Study Director: Emilio Galli, Dr., Ospedale "Treviglio-Caravaggio" di Treviglio
  • Study Director: Cecile Courivaud, Dr., University Hospotal Besancon
  • Study Director: Virpi Rauta, Dr., Helsinki Univerity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PD-aAPD-01-INT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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