UremiaPhase 3ECTDPNCT01583309
Effects of Convective Therapies in Dialysis Patients
A Phase 3 study testing online pre-dilution hemofiltration and online pre-dilution hemodiafiltration in people with Uremia, run by A. Manzoni Hospital at 27 sites in Italy.
Trial summary
Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension. To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uremia
- What is being tested?
- online pre-dilution hemofiltration and online pre-dilution hemodiafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 27 sitesItaly
- Study dates
- Nov 2003to Feb 2008
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis patients aged 18-80 years
- thrice-weekly HD or HDF for at least 6 months
- body weight less or equal to 90 Kg
- stable clinical condition
- written consent
Who cannot join
- infections
- malignancies
- active systemic diseases
- active hepatitis or cirrhosis
- unstable diabetes
- diuresis higher than 200 ml/24h
- dysfunction of vascular access
- blood flow rate less than 300 ml/min
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Italy27 sites
Ospedale S.Marta S.Venera
Acireale (CT)
Ospedale F. Miulli
Acquaviva delle Fonti
Ospedale Civile
Alghero
Ospedale regionale di Aosta
Aosta
Ospedale degli Infermi
Biella
Ospedale SS. Trinità ASL 8
Cagliari
S. Michele Hospital
Cagliari
Ospedale Civile "P. Merlo"
La Maddalena
Alessandro Manzoni Hospital
Lecco
Ospedale "C. POMA"
Mantua
T. EVOLI
Melito di Porto Salvo
Ospedale dell'Angelo
Mestre
Policlinico Multimedica IRCCS
Milan
Federico II
Naples
Ospedale San Francesco
Nuoro
San Giovanni di Dio
Olbia
Ospedale Antonio Segni
Ozieri
Ospedale Maggiore
Parma
Fondazione Maugeri
Pavia
Ospedale " E. AGNELLI "
Pinerolo
Dipartimento territoriale ASL 8
Quartu Sant'Elena
Ospedale S.Maria delle Croci
Ravenna
Azienda Ospedaliera "Bianchi Melacrino Morelli,"
Reggio Calabria
Ospedale Bolognini
Seriate
Ospedale Agostino Landolfi
Solofra
Ospedale San Camillo
Sorgono
ASL 2 Olbia - P.O. "P. Dettori",
Tempio Pausania
About this study
Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension.
To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the investigators performed a multicentre, open-label, randomized controlled trial.
- Conditions
- Uremia
- Being tested
- online pre-dilution hemofiltration, online pre-dilution hemodiafiltration
- Keywords
- blood pressure, cardiovascular instability, symptomatic hypotension, online hemofiltration, online hemodiafiltration
- Medical subject headings
- Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online pre-dilution hemofiltrationProcedure or surgery
Also called online pre-dilution hemofiltration Technique
Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
online pre-dilution hemodiafiltrationProcedure or surgery
Also called online pre-dilution hemodiafiltration Technique
Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.
| Study group | Role | What they receive |
|---|---|---|
| low-flux hemodialysis | No intervention | Not described |
| online pre-dilution hemofiltration | Experimental | Not described Receives: Procedure: online pre-dilution hemofiltration |
| online pre-dilution hemodiafiltration | Experimental | Not described Receives: Procedure: online pre-dilution hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intradialytic symptomatic hypotension
Intradialytic symptomatic hypotension was defined as a rapid symptomatic fall of the systolic blood pressure by at least 30 mmHg or that required nursing and/or medical intervention
Measured: all dialysis sessions, three per week, for 2 years
Secondary outcomes (3)
Resistance to erythropoiesis-stimulating agents
Resistance to erythropoiesis-stimulating agents was measured as (EPO therapy in IU/week)/(Hb in g/dL*body wheight in kg)
Measured: Monthly for 2 years
Calcium-phosphate metabolism
Outcome measures: phosphatemia, calcemia and PTH
Measured: Monthly for 2 years
Beta2 microglobulin
Measured: Every six months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startNov 2003
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for UremiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Manzoni Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Francesco Locatelli, A. Manzoni Hospital
- Investigators
- Francesco Locatelli, Professor, Study chair, A. Manzoni Hospital, Lecco - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583309
- Sponsor's protocol ID
- CONVESTUDY
- Acronym
- ECTDP
- Status last verified
- Apr 2012
- First submitted
- 17 Apr 2012
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bolasco P, Altieri P, Andrulli S, Basile C, Di Filippo S, Feriani M, Pedrini L, Santoro A, Zoccali C, Sau G, Locatelli F. Convection versus diffusion in dialysis: an Italian prospective multicentre study. Nephrol Dial Transplant. 2003 Aug;18 Suppl 7:vii50-4; discussion vii59-62. doi: 10.1093/ndt/gfg1080.
PubMed 12953031Locatelli F, Altieri P, Andrulli S, Bolasco P, Sau G, Pedrini LA, Basile C, David S, Feriani M, Montagna G, Di Iorio BR, Memoli B, Cravero R, Battaglia G, Zoccali C. Hemofiltration and hemodiafiltration reduce intradialytic hypotension in ESRD. J Am Soc Nephrol. 2010 Oct;21(10):1798-807. doi: 10.1681/ASN.2010030280. Epub 2010 Sep 2.
PubMed 20813866Locatelli F, Altieri P, Andrulli S, Sau G, Bolasco P, Pedrini LA, Basile C, David S, Gazzanelli L, Tampieri G, Isola E, Marzolla O, Memoli B, Ganadu M, Reina E, Bertoli S, Ferrara R, Casu D, Logias F, Tarchini R, Mattana G, Passaghe M, Fundoni G, Villa G, Di Iorio BR, Pontoriero G, Zoccali C. Phosphate levels in patients treated with low-flux haemodialysis, pre-dilution haemofiltration and haemodiafiltration: post hoc analysis of a multicentre, randomized and controlled trial. Nephrol Dial Transplant. 2014 Jun;29(6):1239-46. doi: 10.1093/ndt/gfu031. Epub 2014 Feb 20.
PubMed 24557989
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Convective Therapies in Dialysis Patients
- ClinicalTrials.gov ID
- NCT01583309
- Acronym / sponsor ID
- ECTDP / CONVESTUDY
- Conditions
- Uremia
- Keywords
- blood pressure, cardiovascular instability, symptomatic hypotension, online hemofiltration, online hemodiafiltration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- A. Manzoni HospitalUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 24 Apr 2012 (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.
Convective therapies have been proposed for improving chronic dialysis patient outcomes, including intradialytic symptomatic hypotension.
To evaluate the frequency of sessions with intradialytic symptomatic hypotension in different types and doses of convective therapies compared with low-flux hemodialysis (HD), the investigators performed a multicentre, open-label, randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low-flux hemodialysis | No intervention | – |
| online pre-dilution hemofiltration | Experimental | Procedure: online pre-dilution hemofiltration |
| online pre-dilution hemodiafiltration | Experimental | Procedure: online pre-dilution hemodiafiltration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dialysis patients aged 18-80 years
- thrice-weekly HD or HDF for at least 6 months
- body weight less or equal to 90 Kg
- stable clinical condition
- written consent
Key exclusion criteria (8 listed)
- infections
- malignancies
- active systemic diseases
- active hepatitis or cirrhosis
- unstable diabetes
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 |
|---|---|---|
| online pre-dilution hemofiltrationAlso: online pre-dilution hemofiltration TechniqueOnline pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one | Procedure or surgery | online pre-dilution hemofiltration |
| online pre-dilution hemodiafiltrationAlso: online pre-dilution hemodiafiltration TechniqueOnline pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min. | Procedure or surgery | online pre-dilution hemodiafiltration |
Primary outcome
Intradialytic symptomatic hypotension
Time frame: all dialysis sessions, three per week, for 2 years
Intradialytic symptomatic hypotension was defined as a rapid symptomatic fall of the systolic blood pressure by at least 30 mmHg or that required nursing and/or medical intervention
3 secondary outcomes
Resistance to erythropoiesis-stimulating agents
Time frame: Monthly for 2 years
Calcium-phosphate metabolism
Time frame: Monthly for 2 years
Beta2 microglobulin
Time frame: Every six months for 2 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 24 Apr 2012.
- Background: PubMed 12953031Bolasco P, Altieri P, Andrulli S, Basile C, Di Filippo S, Feriani M, Pedrini L, Santoro A, Zoccali C, Sau G, Locatelli F. Convection versus diffusion in dialysis: an Italian prospective multicentre study. Nephrol Dial Transplant. 2003 Aug;18 Suppl 7:vii50-4; discussion vii59-62. doi: 10.1093/ndt/gfg1080.
- Results publication: PubMed 20813866Locatelli F, Altieri P, Andrulli S, Bolasco P, Sau G, Pedrini LA, Basile C, David S, Feriani M, Montagna G, Di Iorio BR, Memoli B, Cravero R, Battaglia G, Zoccali C. Hemofiltration and hemodiafiltration reduce intradialytic hypotension in ESRD. J Am Soc Nephrol. 2010 Oct;21(10):1798-807. doi: 10.1681/ASN.2010030280. Epub 2010 Sep 2.
- Derived from this study: PubMed 24557989Locatelli F, Altieri P, Andrulli S, Sau G, Bolasco P, Pedrini LA, Basile C, David S, Gazzanelli L, Tampieri G, Isola E, Marzolla O, Memoli B, Ganadu M, Reina E, Bertoli S, Ferrara R, Casu D, Logias F, Tarchini R, Mattana G, Passaghe M, Fundoni G, Villa G, Di Iorio BR, Pontoriero G, Zoccali C. Phosphate levels in patients treated with low-flux haemodialysis, pre-dilution haemofiltration and haemodiafiltration: post hoc analysis of a multicentre, randomized and controlled trial. Nephrol Dial Transplant. 2014 Jun;29(6):1239-46. doi: 10.1093/ndt/gfu031. Epub 2014 Feb 20.
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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.
Francesco Locatelli, Professor study chair
A. Manzoni Hospital, Lecco - Italy
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing online pre-dilution hemofiltration and online pre-dilution hemodiafiltration in people with Uremia, run by A. Manzoni Hospital at 27 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 5 inclusion and 8 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 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intradialytic symptomatic hypotension (time frame: all dialysis sessions, three per week, for 2 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 NCT01583309, which also lists 3 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 24 Apr 2012.