Chronic Renal FailureIPOD-PDNCT01285726
Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)
An observational study of Chronic Renal Failure, run by Fresenius Medical Care Deutschland GmbH at 134 sites in 28 countries.
Trial 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. 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?
- Non-interventional study
- How many people
- 1,092 participants
- Where
- 134 sitesin 28 countries
- Study dates
- Jan 2011to Dec 2015
- 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: Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD
Who may be able to join
- Incident patients directly before start of peritoneal dialysis
- Patients in whom routine measurement of body composition monitoring is performed
Who cannot join
- Patients treated with HD before start of PD
- Patients in whom body composition monitoring cannot be performed
Trial locations and contacts
134 sites in 28 countries.
134 sites in 28 countries
Spain34 sites
Hospital Universitario A Coruñ
A Coruña
CHU Albacete
Albacete
Hosp. Univ. Fundacion Alcorcon
Alcorcón
Hospital De Torrecardenas
Almería
Fundació Puigvert
Barcelona
Hospital Clínic de Barcelona
Barcelona
Hospital de Basurto
Bilbao
Hospital de Galdakano
Bilbao
Hospital Univ. Puerta del Mar
Cadiz
Hospital General de Castellón
Castellon
Hospital Josep Trueta
Girona
Complejo Hospitalario de Jaén
Jaén
CAULE
León
Hospital San Pedro
Logroño
Hospital Lucus Augusti
Lugo
Fundación Jiménez Díaz
Madrid
HGU Gregorio Marañon
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Severo Ochoa
Madrid
Hospital Univ. Ramón y Cajal
Madrid
Hospital Universitario Puerta
Madrid
Hospital Carlos Haya
Málaga
Fundación Hospital Manacor
Manacor
Hospital de Mollet
Mollet del Vallès
Hospital Universitario Central
Oviedo
Hospital Univ. de Puerto Real
Puerto Real
HUM Valdecilla
Santander
CHUS
Santiago de Compostela
Hospital Virgen de la Macarena
Seville
Hospital Clínico de Valencia
Valencia
Hospital Rio Hortega
Valladolid
Hospital general de Vic
Vic
CHU Xeral Cies Vigo
Vigo
Hospital Txagorritxu
Vitoria-Gasteiz
Venezuela10 sites
FME Caracas
Caracas
FME Charallave
Charallave
Cenesuca (FME Cumana)
Cumaná
FMC El tigre Edo Anzoátegui
El Tigre
FME Zulia
Maracaibo
FME Maturin
Maturín
FME Puerto de la Cruz
Puerto Cruz
FME Maracay
Turmero
Instituto Docente de Urologia
Valencia
Nefrologico Valencia sur
Valencia
Sweden8 sites
Mälarsjukhuset Eskilstuna
Eskilstuna
Sahlgrenska PD-mottagningen
Gothenburg
Hallands Hospital Halmstad
Halmstad
Sunderby Sjukhus
Luleå
Skånes Universitetssjukhus Malmo
Malmö
Danderyds Hospital
Stockholm
Karolinska Univers. Hospital
Stockholm
Kungsholmsdialysen
Stockholm
Czechia7 sites
University Hospital FN Brno Bohunice
Brno
FN Hradec Kralove
Hradec Králové
DS Most
Most
Faculty Hospital Plzen
Pilsen
IKEM
Prague
VFN Strahov
Prague
Třebíč Hospital
Třebíč
Finland7 sites
Helsinki University Hospital
Helsinki
Central Hospital in Joensuu
Joensuu
Keski-Suomen keskussairaala, Jyväskylä
Jyväskylä
Kymenlaakson keskussairaala, Kotka
Kotka
Oulu University Hospital
Oys
Satakunnan keskussairaala, Pori
Pori
Tampere University Hospital
Tampere
France7 sites
CHU de Bordeaux
Bordeaux
C.H. Dunkerque
Dunkirk
Hôpital Bichat - Claude Bernard
Paris
Centre Hospitalier René Dubos
Pontoise
AUB Quimper / Centre Hospitalier Laennec
Quimper
ECHO Confluent
Rezé
Hôpital Civil de Strasbourg
Strasbourg
Germany7 sites
KfH Nierenzentrum Bottrop
Bottrop
Klinikum Braunschweig
Braunschweig
Nierenzentrum Heidelberg
Heidelberg
Nieren und Hochdruckzentrum Kiel
Kiel
Robert Bosch Krankenhaus
Stuttgart
Nephrologisches Zentrum Velbert Innere Medizin und Nephrologie
Velbert
Nephrologische Praxis Wiesbaden
Wiesbaden
Belgium6 sites
ASZ Aalst
Aalst
ASZ Geraardsbergen
Geraardsbergen
Ghent University Hospital
Ghent
U.Z. Leuven
Leuven
CHU Sart Tilman
Liège
Heilig-Hart Roeselare
Roeselare
Greece5 sites
General University Hospital of Alexandroupolis
Alexandroupoli
General Hospital of Athens G. Gennimatas
Athens
General Hospital of Ioannina
Ioannina
General University Hospital of Ioannina
Ioannina
General University Hospital of Thessaloniki "AHEPA"
Thessaloniki
South Korea5 sites
Yeungnam University Hospital
Daegu
NHIC Ilsan Hospital
Goyang
Konkuk University Medical Center
Seoul
Seoul National University Hospitall
Seoul
Severance Hospital
Seoul
Italy4 sites
UO Nefrologia Policlinico BARI
Bari
Azienda Ospedaliera Brotzu
Cagliari
Ospedale Civico Palermo
Palermo
Ospedale San Bartolo
Vicenza
Norway4 sites
Sykehuset i Møre og Romsdal HF
Ålesund
Nordlandssykehuset Bodø
Bodø
Sykehuset Levanger
Levanger
St. Olavs Hospital
Sluppen
Brazil3 sites
Instituto Mineiro Nefrologia
Belo Horizonte
CDR Barra do Piraí
Piraí
CETENE
São Paulo
Denmark3 sites
Herlev Hospital
Herlev
Hillerød Hospital
Hillerød
Roskilde Hospital
Roskilde
Estonia3 sites
North Estonian Regional Hospital
Tallinn
West Talinn Central Hospital
Tallinn
Tartu University Hospital
Tartu
Lithuania3 sites
Kaunas clinics
Kaunas
Klaipeda Republic Hospital
Klaipėda
Vilnius Univ. Antakalnio Hospital
Vilnius
Portugal2 sites
Hospital Santa Cruz
Carnaxide
CHP Hospital Santo Antonio
Porto
United Kingdom2 sites
Western Infirmary Glasgow
Glasgow
Royal London Hospital
London
About this study
Official title: Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)
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.
Read the detailed description
Achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (PD) patients. With the recent development of a new bioimpedance spectroscopy (BIS) device, the BCM-Body Composition Monitor (BCM), it is now possible to quantify deviations of hydration status and to define target weight directly.
It has been observed that more than 50% of the PD patients are overhydrated, as compared to the healthy population. This overhydration seems to be associated with modifiable practice-related factors, such as correct PD prescription according to membrane transport status, and dietary fluid intake.
The aim of this study is to assess the hydration status of incident PD patients, and diagnose the underlying reasons for incorrect fluid status. In addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered.
The investigators assume that the use of the BCM-Body Composition Monitor (BCM) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. Hence, the BCM allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.
- Conditions
- Chronic Renal Failure
- Being tested
- Non-interventional study
- Keywords
- Peritoneal dialysis, Hydration status, Residual renal function, Bioimpedance spectroscopy, Body composition monitor
- 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.
Non-interventional studyOther
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 (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW)) (Overhydration, total body water (TBW), extracellular water (ECW), intracellular water (ICW))
Measured: Every three months over a period of four years
Secondary outcomes (4)
Residual renal function
Measured: Every three months over a period of four years
Peritoneal transport status
Measured: Every three months over a period of four years
Time to change to haemodialysis
Measured: Four years
Changes in PD prescription
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 1,092 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio Ronco, Prof, Study chair, Ospedale San BartoloWim Van Biesen, Prof, Study chair, University Hospital, GhentChristian Verger, Dr, Study chair, French Language PD Registry (RDPLF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285726
- Sponsor's protocol ID
- BCM-PD-02-INT
- Acronym
- IPOD-PD
- Status last verified
- Apr 2016
- First submitted
- 26 Jan 2011
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35004718Ronco 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.
PubMed 25762355
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiative for Patient Outcomes in Dialysis - PD (IPOD-PD Study)
- ClinicalTrials.gov ID
- NCT01285726
- Acronym / sponsor ID
- IPOD-PD / BCM-PD-02-INT
- Conditions
- Chronic Renal Failure
- Keywords
- Peritoneal dialysis, Hydration status, Residual renal function, Bioimpedance spectroscopy, Body composition monitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,092 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jan 2011 (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 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.
Detailed description
Achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (PD) patients. With the recent development of a new bioimpedance spectroscopy (BIS) device, the BCM-Body Composition Monitor (BCM), it is now possible to quantify deviations of hydration status and to define target weight directly.
It has been observed that more than 50% of the PD patients are overhydrated, as compared to the healthy population. This overhydration seems to be associated with modifiable practice-related factors, such as correct PD prescription according to membrane transport status, and dietary fluid intake.
The aim of this study is to assess the hydration status of incident PD patients, and diagnose the underlying reasons for incorrect fluid status. In addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered.
The investigators assume that the use of the BCM-Body Composition Monitor (BCM) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. Hence, the BCM allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.
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
- Adult patients with chronic kidney disease (CKD) starting renal replacement therapy on APD or CAPD
Key inclusion criteria (2 listed)
- Incident patients directly before start of peritoneal dialysis
- Patients in whom routine measurement of body composition monitoring is performed
Key exclusion criteria (2 listed)
- Patients treated with HD before start of PD
- Patients in whom body composition monitoring cannot be performed
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 |
|---|---|---|
| Non-interventional studyThis 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 over a period of four years
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))
4 secondary outcomes
Residual renal function
Time frame: Every three months over a period of four years
Peritoneal transport status
Time frame: Every three months over a period of four years
Time to change to haemodialysis
Time frame: Four years
Changes in PD prescription
Time frame: Four years
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 May 2016.
- Derived from this study: PubMed 35004718Verger 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.
- Derived from this study: PubMed 25762355Ronco 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.
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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.
Claudio Ronco, Prof study chair
Ospedale San Bartolo
Wim Van Biesen, Prof study chair
University Hospital, Ghent
Christian Verger, Dr study chair
French Language PD Registry (RDPLF)
134 sites in 28 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 134 sites in 28 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 2 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 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 134 sites in Spain, Venezuela, Sweden, Czechia, Finland and 23 more countries. 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 over a period of four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01285726, which also lists 2 linked publications.
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 May 2016.