NCT01285726

Brief Summary

The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
1,092

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
27 countries

131 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

January 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

4.9 years

First QC Date

January 26, 2011

Last Update Submit

April 29, 2016

Conditions

Keywords

Peritoneal dialysisHydration statusResidual renal functionBioimpedance spectroscopyBody composition monitor

Outcome Measures

Primary Outcomes (1)

  • Hydration status

    Assessed via body composition measurements (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW)) (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW))

    Every three months over a period of four years

Secondary Outcomes (4)

  • Residual renal function

    Every three months over a period of four years

  • Peritoneal transport status

    Every three months over a period of four years

  • Time to change to haemodialysis

    Four years

  • Changes in PD prescription

    Four years

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

Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD

You may qualify if:

  • Incident patients directly before start of peritoneal dialysis
  • Patients in whom routine measurement of body composition monitoring is performed

You may not qualify if:

  • Patients treated with HD before start of PD
  • Patients in whom body composition monitoring cannot be performed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (134)

Klinikum Wels

Wels, Austria

Location

ASZ Aalst

Aalst, Belgium

Location

ASZ Geraardsbergen

Geraardsbergen, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

U.Z. Leuven

Leuven, Belgium

Location

CHU Sart Tilman

Liège, Belgium

Location

Heilig-Hart Roeselare

Roeselare, Belgium

Location

KBC Mostar

Mostar, Bosnia and Herzegovina

Location

UKC Tuzla

Tuzla, Bosnia and Herzegovina

Location

Instituto Mineiro Nefrologia

Belo Horizonte, Brazil

Location

CDR Barra do Piraí

Piraí, Brazil

Location

CETENE

São Paulo, Brazil

Location

UHC Osijek

Osijek, Croatia

Location

UH Split

Split, Croatia

Location

UH Merkur

Zagreb, Croatia

Location

Instituto de Nefrología

La Habana, Cuba

Location

University Hospital FN Brno Bohunice

Brno, Czechia

Location

FN Hradec Kralove

Hradec Králové, Czechia

Location

DS Most

Most, Czechia

Location

Faculty Hospital Plzen

Pilsen, Czechia

Location

IKEM

Prague, Czechia

Location

VFN Strahov

Prague, Czechia

Location

Třebíč Hospital

Třebíč, Czechia

Location

Herlev Hospital

Herlev, Denmark

Location

Hillerød Hospital

Hillerød, Denmark

Location

Roskilde Hospital

Roskilde, Denmark

Location

North Estonian Regional Hospital

Tallinn, Estonia

Location

West Talinn Central Hospital

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

Helsinki University Hospital

Helsinki, Finland

Location

Central Hospital in Joensuu

Joensuu, Finland

Location

Keski-Suomen keskussairaala, Jyväskylä

Jyväskylä, Finland

Location

Kymenlaakson keskussairaala, Kotka

Kotka, Finland

Location

Oulu University Hospital

Oys, Finland

Location

Satakunnan keskussairaala, Pori

Pori, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

CHU de Bordeaux

Bordeaux, France

Location

C.H. Dunkerque

Dunkirk, France

Location

Hôpital Bichat - Claude Bernard

Paris, France

Location

Centre Hospitalier René Dubos

Pontoise, France

Location

AUB Quimper / Centre Hospitalier Laennec

Quimper, France

Location

ECHO Confluent

Rezé, France

Location

Hôpital Civil de Strasbourg

Strasbourg, France

Location

KfH Nierenzentrum Bottrop

Bottrop, Germany

Location

Klinikum Braunschweig

Braunschweig, Germany

Location

Nierenzentrum Heidelberg

Heidelberg, Germany

Location

Nieren und Hochdruckzentrum Kiel

Kiel, Germany

Location

Robert Bosch Krankenhaus

Stuttgart, Germany

Location

Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie

Velbert, Germany

Location

Nephrologische Praxis Wiesbaden

Wiesbaden, Germany

Location

General University Hospital of Alexandroupolis

Alexandroupoli, Greece

Location

General Hospital of Athens G. Gennimatas

Athens, Greece

Location

General Hospital of Ioannina

Ioannina, Greece

Location

General University Hospital of Ioannina

Ioannina, Greece

Location

General University Hospital of Thessaloniki "AHEPA"

Thessaloniki, Greece

Location

MMM - Chennai

Chennai, India

Location

Western Galilee Hospital

Nahariya, Israel

Location

UO Nefrologia Policlinico BARI

Bari, Italy

Location

Azienda Ospedaliera Brotzu

Cagliari, Italy

Location

Ospedale Civico Palermo

Palermo, Italy

Location

Ospedale San Bartolo

Vicenza, Italy

Location

Med Alfa Ltda

Riga, Latvia

Location

P. Stradins hospital

Riga, Latvia

Location

Kaunas clinics

Kaunas, Lithuania

Location

Klaipeda Republic Hospital

Klaipėda, Lithuania

Location

Vilnius Univ. Antakalnio Hospital

Vilnius, Lithuania

Location

University Hospital Maastricht

Maastricht, Netherlands

Location

Sykehuset i Møre og Romsdal HF

Ålesund, Norway

Location

Nordlandssykehuset Bodø

Bodø, Norway

Location

Sykehuset Levanger

Levanger, Norway

Location

St. Olavs Hospital

Sluppen, Norway

Location

Hospital Santa Cruz

Carnaxide, Portugal

Location

CHP Hospital Santo Antonio

Porto, Portugal

Location

Yeungnam University Hospital

Daegu, South Korea

Location

NHIC Ilsan Hospital

Goyang, South Korea

Location

Konkuk University Medical Center

Seoul, South Korea

Location

Seoul National University Hospitall

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Hospital Universitario A Coruñ

A Coruña, Spain

Location

CHU Albacete

Albacete, Spain

Location

Hosp. Univ. Fundacion Alcorcon

Alcorcón, Spain

Location

Hospital De Torrecardenas

Almería, Spain

Location

Fundació Puigvert

Barcelona, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital de Galdakano

Bilbao, Spain

Location

Hospital Univ. Puerta del Mar

Cadiz, Spain

Location

Hospital General de Castellón

Castellon, Spain

Location

Hospital Josep Trueta

Girona, Spain

Location

Complejo Hospitalario de Jaén

Jaén, Spain

Location

CAULE

León, Spain

Location

Hospital San Pedro

Logroño, Spain

Location

Hospital Lucus Augusti

Lugo, Spain

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

HGU Gregorio Marañon

Madrid, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Severo Ochoa

Madrid, Spain

Location

Hospital Univ. Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Puerta

Madrid, Spain

Location

Fundación Hospital Manacor

Manacor, Spain

Location

Hospital Carlos Haya

Málaga, Spain

Location

Hospital de Mollet

Mollet del Vallès, Spain

Location

Hospital Universitario Central

Oviedo, Spain

Location

Hospital Univ. de Puerto Real

Puerto Real, Spain

Location

HUM Valdecilla

Santander, Spain

Location

CHUS

Santiago de Compostela, Spain

Location

Hospital Virgen de la Macarena

Seville, Spain

Location

Hospital Clínico de Valencia

Valencia, Spain

Location

Hospital Rio Hortega

Valladolid, Spain

Location

Hospital general de Vic

Vic, Spain

Location

CHU Xeral Cies Vigo

Vigo, Spain

Location

Hospital Txagorritxu

Vitoria-Gasteiz, Spain

Location

Mälarsjukhuset Eskilstuna

Eskilstuna, Sweden

Location

Sahlgrenska PD-mottagningen

Gothenburg, Sweden

Location

Hallands Hospital Halmstad

Halmstad, Sweden

Location

Sunderby Sjukhus

Luleå, Sweden

Location

Skånes Universitetssjukhus Malmo

Malmo, Sweden

Location

Danderyds Hospital

Stockholm, Sweden

Location

Karolinska Univers. Hospital

Stockholm, Sweden

Location

Kungsholmsdialysen

Stockholm, Sweden

Location

Luzern Kantonsspital

Lucerne, Switzerland

Location

Akdeniz Universitesi

Antalya, Turkey (Türkiye)

Location

Western Infirmary Glasgow

Glasgow, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

FME Caracas

Caracas, Venezuela

Location

FME Charallave

Charallave, Venezuela

Location

Cenesuca (FME Cumana)

Cumaná, Venezuela

Location

FMC El tigre Edo Anzoátegui

El Tigre, Venezuela

Location

FME Zulia

Maracaibo, Venezuela

Location

FME Maturin

Maturín, Venezuela

Location

FME Puerto de la Cruz

Puerto Cruz, Venezuela

Location

FME Maracay

Turmero, Venezuela

Location

Instituto Docente de Urologia

Valencia, Venezuela

Location

Nefrologico Valencia sur

Valencia, Venezuela

Location

Related Publications (2)

  • Verger C, Ronco C, Van Biesen W, Heaf J, Vrtovsnik F, Vera Rivera M, Puide I, Azar R, Gauly A, Atiye S, De Los Rios T. Association of Prescription With Body Composition and Patient Outcomes in Incident Peritoneal Dialysis Patients. Front Med (Lausanne). 2021 Dec 24;8:737165. doi: 10.3389/fmed.2021.737165. eCollection 2021.

  • Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.

MeSH Terms

Conditions

Kidney Failure, Chronic

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

  • Claudio Ronco, Prof

    Ospedale San Bartolo

    STUDY CHAIR
  • Wim Van Biesen, Prof

    University Hospital, Ghent

    STUDY CHAIR
  • Christian Verger, Dr

    French Language PD Registry (RDPLF)

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 26, 2011

First Posted

January 28, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations