NCT02470598

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Geographic Reach
6 countries

50 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 6, 2020

Status Verified

July 1, 2020

Enrollment Period

5.3 years

First QC Date

April 28, 2015

Last Update Submit

August 5, 2020

Conditions

Keywords

Automated Peritoneal DialysisAdapted APD (aAPD)Hydration statusResidual Renal FunctionUltrafiltration

Outcome Measures

Primary Outcomes (1)

  • Hydration status

    Assessed via body composition measurements

    Every three months during one year

Secondary Outcomes (4)

  • Residual renal function

    Every three months during one year

  • Changes in prescription

    Every three months during one year

  • Achievement of adequate solute removal

    Every three months during one year

  • Therapy tolerability

    Every three months during one year

Other Outcomes (1)

  • Change of therapy modality

    Every three months during one year

Interventions

This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (50)

Faculty Hospital Brno-Bohunice

Brno, Czechia

Location

Hospital Liberec

Liberec, Czechia

Location

Regional Hospital in Mlada Boleslav

Mladá Boleslav, Czechia

Location

Hospital Nove Mesto na Morave

Nové Město na Moravě, Czechia

Location

Faculty Hospital Pilsen

Pilsen, Czechia

Location

Faculty Hospital Karlovo namesti

Prague, Czechia

Location

Faculty Hospital Strahov

Prague, Czechia

Location

NC centre Vinohrady

Prague, Czechia

Location

NC centre Sokolov

Sokolov, Czechia

Location

Hospital Trebic

Třebíč, Czechia

Location

Regional Hospital Viborg

Viborg, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Kymenlaakso Central Hospital

Kotka, Finland

Location

Regional Hospital Roskilde

Lappeenranta, Finland

Location

Hospital Selayang

Batu Caves, Malaysia

Location

Gleneagles Hospital Kuala Lumpur (GHKL)

Kuala Lumpur, Malaysia

Location

Hospital Universiti Kebangsaan Malaysia (HUKM)

Kuala Lumpur, Malaysia

Location

Hospital Serdang

Serdang, Malaysia

Location

Hospital Seremban

Seremban, Malaysia

Location

Complejo Hospitalario universitario de Albacete

Albacete, Spain

Location

Fundación Hospital de Alcorcón

Alcorcón, Spain

Location

Complejo Asistencial de Avila

Ávila, Spain

Location

Fundacion Puigvert

Barcelona, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital General de Castellón

Castellon, Spain

Location

Hospital Universitario di Girona Josep Trueta

Girona, Spain

Location

Hospital General Virgen de las Nieves

Granada, Spain

Location

Complejo hospitalario de Jaén

Jaén, Spain

Location

Complejo Hospitalario San Millán-San Pedro De La Rioja

Logroño, Spain

Location

Hospital Universitario Lucus Agusti

Lugo, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

Complexo Hospitalario Universitario de Ourense (CHUO)

Ourense, Spain

Location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Spain

Location

Hospital Universitatio Donostia

San Sebastián, Spain

Location

Complejo Hospital Universitario de Santiago (CHUS)

Santiago de Compostela, Spain

Location

Hospital Clínico de Valencia

Valencia, Spain

Location

Hospital Peset

Valencia, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, Spain

Location

Danderyds Sjukhus AB

Danderyd, Sweden

Location

Höglandssjukhuset Eksjö/Nässjö

Eksjö, Sweden

Location

Kalmar Hospital

Kalmar, Sweden

Location

Skåne University Hospital

Lund, Sweden

Location

Länssjukhuset Sundsvall

Sundsvall, Sweden

Location

Norra Älvsborgs Länssjukhus

Trollhättan, Sweden

Location

Norrlands University Hopsital

Umeå, Sweden

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2015

First Posted

June 12, 2015

Study Start

March 1, 2015

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

August 6, 2020

Record last verified: 2020-07

Locations