End Stage Renal DiseaseCHDvsSDHDNCT02002949
Conventional Hemodialysis Vs Short Daily Hemodialysis for Patients Coming From Peritoneal Dialysis (HAPD/CAPD)
A study testing Short daily hemodialysis and Conventional hemodialysis in people with End Stage Renal Disease, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 31 sites in Italy.
Trial summary
The purpose of this randomized study is to determine if the home SDHD is a suitable alternative to conventional dialysis performed in a dialysis center for patients suffering from chronic kidney disease from Peritoneal Dialysis (HAPD/CAPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Short daily hemodialysis and Conventional hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 31 sitesItaly
- Study dates
- Feb 2014to Dec 2017
- Phase
- Interventional
- 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
Who may be able to join
- Diagnosis of end-stage renal disease
- Currently performing Peritoneal Dialysis (HAPD and CAPD) for a minimum of 3 months.
- Age 18 years or older.
- Suitability for SDHD, determined on the basis of the following conditions:
- willingness to be trained and perform frequent hemodialysis at home;
- physically and mentally capable of performing frequent hemodialysis at home;
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- evaluation of the subject's home environment by a physician, training nurse and /or social worker;
- a home dialysis partner willing to assist the participant in performing treatments at home;
- agreement by a multidisciplinary (physician, nurse and any other professionals) team that the subject is suitable for SDHD.
- Expected survival of at least one year.
- Ability to understand and willingness to sign an informed consent statement.
Who cannot join
- Current enrollment in another investigational drug or device trial which might impact the outcomes measures planned in this study.
- Being scheduled for change of modality or plans to relocate to an area outside of the clinical center.
- Cancer
- Pregnancy-lactation.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
Italy31 sites, 31 recruiting
- Not yet recruiting
Ospedale Santa Marta e Santa Venera di Acireale
Acireale
Giovanni Giorgio Battaglia
- Not yet recruiting
A.O.U. Ospedali Riuniti di Ancona
Ancona
Giovanni Frascà
- Recruiting
Presidio Ospedaliero 1 - Arezzo, "San Donato"
Arezzo
Ennio Duranti
- Recruiting
AUO Policlinico Consorziale
Bari, BA, 70125
Loreto GESUALDO, MD, +39 080 559 ext. 4041, loreto.gesualdo@uniba.it
Loreto GESUALDO, MD
- Not yet recruiting
Policlinico Universitario S. Orsola-Malpighi
Bologna
Gaetano La Manna
- Not yet recruiting
Azienda Ospedaliera G. Brotzu
Cagliari
Antonello Pani
- Recruiting
Ospedale S. Giacomo Apostolo
Castelfranco Veneto
Cataldo Abaterusso
- Not yet recruiting
Ospedale per l'emergenza Cannizzaro Catania
Catania
Massimo Matalone
- Not yet recruiting
Ospedale SS.Annunziata
Chieti
Mario Bonomini
- Not yet recruiting
Ospedale Civile di Cremona
Cremona
Fabio Malberti
- Recruiting
Azienda Ospedaliero Universitaria "OO.RR." di Foggia
Foggia
Giuseppe Grandaliano
- Recruiting
ASL 12 Di Viareggio - Ospedale Versilia
Lido di Camaiore
Vincenzo Panichi
- Recruiting
Seconda Università degli Studi di Napoli
Naples
Giovambattista Capasso
- Not yet recruiting
Secondo Policlinico-Azienda Ospedaliera Universitaria "Federico II"
Naples
Stefano Federico
- Not yet recruiting
Secondo Ospedale S. Francesco, ASL 3 S
Nuoro
Maria Maddalena Sedda
- Not yet recruiting
Ospedale Civile Spirito Santo
Pescara
Mario Campanella
- Not yet recruiting
Ospedale Civile di Piacenza
Piacenza
Roberto Scarpioni
- Not yet recruiting
Azienda Ospedaliera Universitaria Pisana
Pisa
Francesca Egidi
- Not yet recruiting
Ospedale G. B. Grassi
Roma
Massimo Morosetti
- Recruiting
Università Cattolica Del Sacro Cuore
Roma
Giovanni Gambaro
- Not yet recruiting
Ospedale Santa Maria della Misericordia
Rovigo
Fulvio Fiorini
- Recruiting
Ospedale D. Anna
San Fermo della Battaglia
Claudio Minoretti
- Not yet recruiting
Ospedale Civile San Giovanni Di Dio
San Michele
Antonio Granata
- Not yet recruiting
Ospedale Principe di Piemonte
Senigallia
Rolando Boggi
- Not yet recruiting
Ospedale Umberto I di Siracusa
Syracuse
Giuseppe Daidone
- Not yet recruiting
Ospedale Mazzini
Teramo
Goffredo Del Rosso
- Not yet recruiting
Ospedale San giovanni Battista Molinette
Torino
Luigi Biancone
- Not yet recruiting
Ospedale San giovanni Bosco
Torino
Dario Roccatello
- Not yet recruiting
Ospedale Santa Chiara
Trento
Giuliano Brunori
- Recruiting
Ospedale Treviglio - Caravaggio
Treviglio
Silvia Cassamali
- Recruiting
Ospedale Civile di Voghera
Voghera
Fabio Milanesi
About this study
Official title: Cost-Utility of Conventional Hemodialysis (CHD) Vs Short Daily Hemodialysis (SDHD) for Patients Coming From Peritoneal Dialysis (HAPD/CAPD): A Randomized Controlled Trial
The purpose of this randomized study is to determine if the home SDHD is a suitable alternative to conventional dialysis performed in a dialysis center for patients suffering from chronic kidney disease from Peritoneal Dialysis (HAPD/CAPD).
The adequacy of this alternative dialysis technique confirms that the SDHD at home is a viable option for patients coming from HAPD/CAPD and indeed support the clinical benefits of home SDHD compared with those of conventional dialysis: lowering blood pressure and lower use of antihypertensive drugs , improving the quality of life, maintenance of residual renal function related to a reduced risk of death and reduction in operating costs of dialysis and patient transport.
Read the detailed description
Conventional Hemodialysis - 3 treatments per week for approximately 4 hours- will be performed in a dialysis clinic using any hemodialysis machine. Short Daily Hemodialysis - 5 or 6 treatments per week for approximately 2-4 hours per treatment- will be performed in the patient's home, using any hemodialysis machine. Partecipants randomized to SDHD will undergo an intensive home hemodialysis training program expected to take 2-6 weeks to complete. Qualified healthcare professionals will train each SDHD subject's partner to perform dialysis using any hemodialysis machine as chosen by clinicians. At baseline visit, before the first study treatment in either the SDHD or CHD arm, the following data will be collected: demographic information, ESRD history, EuroQol EQ-5D-5L questionnaire, vital sign, blood laboratory test results, KT/V parameters, 24 hour timed urine collection test results, comorbid conditions, vascular access type, current medications. After hemodialysis start, patients will be followed up to 12 months with data collection at 1,3,6 and 12 months. At each visit, the following data will be collected: EuroQol EQ-5D-5L questionnaire, vital sign, blood laboratory test results, KT/V parameters, 24 hour timed urine collection test results, adverse events, vascular access type, current medications. During this study, the following parameters will be strictly monitored: treatment costs, medications, number of hospitalization admissions, number of days in hospital and reasons for hospitalizations, additional costs informations.
Home hemodialysis could be an integrated therapeutic option favoring the de-hospitalization of patients requiring hemodialysis. Aim of this study is to offer the patient a better quality of life, to create the conditions for an improvement in blood pressure, phosphate control, of cardiovascular morbidity and mortality, and to reduce costs for the National Health Service.
- Conditions
- End Stage Renal Disease
- Being tested
- Short daily hemodialysis, Conventional hemodialysis
- Keywords
- Hemodialysis
- 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.
Short daily hemodialysisProcedure or surgery
5 or 6 treatments per week for approximately 3 hours (range 2 to 4 hours) per treatment, to be performed at the patient's home, using any hemodialysis machine as chosen by the responsible clinician in each participating center
Conventional hemodialysisProcedure or surgery
3 treatments per week for approximately 4 hours (range 3 hours and 30 minutes to 4 hours) per treatment, to be performed in a dialysis clinic using any hemodialysis machine as chosen by the responsible clinicians in each participating center
| Study group | Role | What they receive |
|---|---|---|
| Short daily hemodialsysis | Experimental | Short Daily Hemodialysis (SDHD) - 5 or 6 treatments per week for approximately 3 hours (range 2 to 4 hours) per treatment, to be performed at the patient's home, using any hemodialysis machine as chosen by the responsible clinician in each participating center Receives: Procedure: Short daily hemodialysis |
| Conventional hemodialysis | Active comparator | Conventional Hemodialysis (CHD) - 3 treatments per week for approximately 4 hours (range 3 hours and 30 minutes to 4 hours) per treatment, to be performed in a dialysis clinic using any hemodialysis machine as chosen by the responsible clinicians in each participating center Receives: Procedure: Conventional hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean quality-adjusted life year (QALY) score in the first year after the start of dialysis
Measured: one year
Secondary outcomes (8)
dialysis related cost of care
Measured: one year
transportation costs per patient per year for the journeys "home-hospital-home"
Measured: one year
ratio nurse/patients
Measured: one year
hospitalization rate (admissions and days
Measured: one year
weekly standardized Kt/V delivered
Measured: one year
systolic blood pressure and use of antihypertensive medications
blood pressure will be assessed for a year and measured in mmHg. It will be evaluated if the patient will need to increase the antihypertensive therapy or to reduce it
Measured: one year
mineral metabolism, anemia parameters and nutritional parameters
As of mineral metabolism, it will be assessed serum calcium levels (expressed in mg per deciliter), serum phosphorus levels (expressed in mg per deciliter), parathormone levels (expressed in pg/ml). As of anemia, it will evaluated hemoglobin levels (expressed in g per deciliter), hematocrit (expressed in %), serum ferritin (μg/l) , transferrin saturation (expressed in %). Albumin (g/dl) will be a nutritional parameter
Measured: one year
maintenance of residual renal function
it will be assessed residual diuresis per day expressed in ml and residual creatinine clearance expressed in ml/min
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionNov 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Loreto GESUALDO, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Investigators
- Loreto LG GESUALDO, MD, Principal investigator, AOUConsorziale, Bari, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002949
- Sponsor's protocol ID
- RF-2010-2314193
- Acronym
- CHDvsSDHD
- Status last verified
- Mar 2016
- First submitted
- 20 Nov 2013
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Utility of Conventional Hemodialysis (CHD) Vs Short Daily Hemodialysis (SDHD) for Patients Coming From Peritoneal Dialysis (HAPD/CAPD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02002949
- Acronym / sponsor ID
- CHDvsSDHD / RF-2010-2314193
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Dec 2013 (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 purpose of this randomized study is to determine if the home SDHD is a suitable alternative to conventional dialysis performed in a dialysis center for patients suffering from chronic kidney disease from Peritoneal Dialysis (HAPD/CAPD).
The adequacy of this alternative dialysis technique confirms that the SDHD at home is a viable option for patients coming from HAPD/CAPD and indeed support the clinical benefits of home SDHD compared with those of conventional dialysis: lowering blood pressure and lower use of antihypertensive drugs , improving the quality of life, maintenance of residual renal function related to a reduced risk of death and reduction in operating costs of dialysis and patient transport.
Detailed description
Conventional Hemodialysis - 3 treatments per week for approximately 4 hours- will be performed in a dialysis clinic using any hemodialysis machine. Short Daily Hemodialysis - 5 or 6 treatments per week for approximately 2-4 hours per treatment- will be performed in the patient's home, using any hemodialysis machine. Partecipants randomized to SDHD will undergo an intensive home hemodialysis training program expected to take 2-6 weeks to complete. Qualified healthcare professionals will train each SDHD subject's partner to perform dialysis using any hemodialysis machine as chosen by clinicians. At baseline visit, before the first study treatment in either the SDHD or CHD arm, the following data will be collected: demographic information, ESRD history, EuroQol EQ-5D-5L questionnaire, vital sign, blood laboratory test results, KT/V parameters, 24 hour timed urine collection test results, comorbid conditions, vascular access type, current medications. After hemodialysis start, patients will be followed up to 12 months with data collection at 1,3,6 and 12 months. At each visit, the following data will be collected: EuroQol EQ-5D-5L questionnaire, vital sign, blood laboratory test results, KT/V parameters, 24 hour timed urine collection test results, adverse events, vascular access type, current medications. During this study, the following parameters will be strictly monitored: treatment costs, medications, number of hospitalization admissions, number of days in hospital and reasons for hospitalizations, additional costs informations.
Home hemodialysis could be an integrated therapeutic option favoring the de-hospitalization of patients requiring hemodialysis. Aim of this study is to offer the patient a better quality of life, to create the conditions for an improvement in blood pressure, phosphate control, of cardiovascular morbidity and mortality, and to reduce costs for the National Health Service.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short daily hemodialsysis | Experimental | Procedure: Short daily hemodialysisShort Daily Hemodialysis (SDHD) - 5 or 6 treatments per week for approximately 3 hours (range 2 to 4 hours) per treatment, to be performed at the patient's home, using any hemodialysis machine as chosen by the responsible clinician in each participating center |
| Conventional hemodialysis | Active comparator | Procedure: Conventional hemodialysisConventional Hemodialysis (CHD) - 3 treatments per week for approximately 4 hours (range 3 hours and 30 minutes to 4 hours) per treatment, to be performed in a dialysis clinic using any hemodialysis machine as chosen by the responsible clinicians in each participating center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of end-stage renal disease
- Currently performing Peritoneal Dialysis (HAPD and CAPD) for a minimum of 3 months.
- Age 18 years or older.
- Suitability for SDHD, determined on the basis of the following conditions:
- Expected survival of at least one year.
Key exclusion criteria (4 listed)
- Current enrollment in another investigational drug or device trial which might impact the outcomes measures planned in this study.
- Being scheduled for change of modality or plans to relocate to an area outside of the clinical center.
- Cancer
- Pregnancy-lactation.
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 |
|---|---|---|
| Short daily hemodialysis5 or 6 treatments per week for approximately 3 hours (range 2 to 4 hours) per treatment, to be performed at the patient's home, using any hemodialysis machine as chosen by the responsible clinician in each participating center | Procedure or surgery | Short daily hemodialsysis |
| Conventional hemodialysis3 treatments per week for approximately 4 hours (range 3 hours and 30 minutes to 4 hours) per treatment, to be performed in a dialysis clinic using any hemodialysis machine as chosen by the responsible clinicians in each participating center | Procedure or surgery | Conventional hemodialysis |
Primary outcome
mean quality-adjusted life year (QALY) score in the first year after the start of dialysis
Time frame: one year
8 secondary outcomes
dialysis related cost of care
Time frame: one year
transportation costs per patient per year for the journeys "home-hospital-home"
Time frame: one year
ratio nurse/patients
Time frame: one year
hospitalization rate (admissions and days
Time frame: one year
weekly standardized Kt/V delivered
Time frame: one year
systolic blood pressure and use of antihypertensive medications
Time frame: one year
mineral metabolism, anemia parameters and nutritional parameters
Time frame: one year
maintenance of residual renal function
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2016.
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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.
Loreto LG GESUALDO, MD principal investigator
AOUConsorziale, Bari, Italy
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short daily hemodialysis and Conventional hemodialysis in people with End Stage Renal Disease, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 31 sites in Italy.
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 11 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Loreto GESUALDO, MD (+39 080 559 ext. 4041, loreto.gesualdo@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean quality-adjusted life year (QALY) score in the first year after the start of dialysis (time frame: 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 9 Mar 2016.