ESRDHEPHAESTUSNCT02863016

Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers

An observational study of ESRD, run by Ospedale Santa Maria Annunziata at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: ESRD
What is being tested?: SelectBag One
Type of treatment: Medical device
How many people: 66 participants
Where: 3 sitesItaly
Study dates: Jul 2016to Apr 2017
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: * Patients clinically stable. * age> 18. * HDF in renal replacement therapy for more than 1 month. * good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

Who may be able to join

. Patients clinically stable.
age> 18.
HDF in renal replacement therapy for more than 1 month.
good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

Who cannot join

Life expectancy <3 months.
With residual renal function> 500 ml / day.
Vascular access with CVC

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

Ospedale Santa Maria Annunziata
Florence, Fi
Ospedale Versilia
Lido di Camaiore, Lucca
Ospedale Campo di Marte
Lucca

Other trials in Italy

About this study

Official title: tHe Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers in TUscan Prevalent Hemodialysis patientS: HEPHAESTUS Study

The aim of this study was to evaluate the effect and timing of action on the inflammatory state of a acetate-free containing citrate concentrate (Cit-, 1 mM Citrate) in online postidultion HDF with high volumes compared to traditional concentrated (Ac-, 3 mM of acetate ) in the medium term. In addition, the study will evaluate other parameters of efficiency dialysis, cardiovascular stability, the safety of the concentrate with regard to bone metabolism and vessel calcification in the medium term.

Read the detailed description

The primary objective of this study was to evaluate if a hemodiafiltration with concentrated citrate (Cit-HDF) in 3 months can reduce the inflammation markers, evaluated by a Predialytic value of Beta2-microglobulin (B2m), CRP and IL6 compared to traditional concentrated acetic acid (Ac-HDF).

The secondary objectives of this study are to evaluate if Cit-HDF, compared to Ac-HDF, can have an effect in a period of 3 months on the following aspects:

the change weekly pre-dialysis values of other markers of oxidative stress (TAC, NF-kB);
the technical parameters of HDF treatment, such as convective volumes, and blood pressure in the circuit in the filter (TMP, pressure pre-filter);
the cardiovascular stability through blood pressure and heart rate before and after dialysis (SBP, DBP, HR) and number of intradialytic hypotension;
the parameters of safety as the variation of the values of the mobility Predialytic bone (PTH, alkaline phosphatase, fetuin-A), the variation of the values intradialytic biochemical impacted by citrate (total and ionized calcium, bicarbonate) and clotting time (aPTT);
the variation of calcifications observed by:
the expression of molecules that express the ability of calcification of muscle cells and endothelial cells in culture with plasma taken at the beginning of treatment
a measure of carotid intimal thickness and pulse vawe velocity by Eco Color Doppler (optional);
dialysis efficiency by varying pre-and post-dialysis (RR%) and Clearance average molecular weight solutes with small and medium (Phosphorus, Beta2 Micro, Myoglobin) and indices of dialysis adequacy of small molecules such as EKT / V based on the dialysance ion formula Watson (calculated automatically by the monitor to dialysis);

Conditions: ESRD
Being tested: SelectBag One
Keywords: dialysis, hemodiafiltration
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.

SelectBag OneDevice
Also called SelectBag Citrate
Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution with two kind of concentrates: acetic acid (Ac-HDF) and acetate-free citrate containing one (HDF-Cit ). For each of the sessions will be used online HDF postdilution with TMP biofeedback (UltraControl) and Filter high permeability.

Study groups in NCT02863016
Study group	Role	What they receive
Concentrate SelectBag One		Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution: first of all concentrate SelectBag One (with 3 mM of acetic acid and 0 mM of citrate) Receives: Device: SelectBag One
Concentrate SelectBag Citrate		Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution, then with SelectBag Citrate (with 0 mM of acetic acid and 1 mM of citric acid) Receives: Device: SelectBag One

What is being measured

The primary outcome is the main question the study is designed to answer.

Inflammation
Value of IL-6
Measured: 3 months

Secondary outcomes (1)

Dialytic dose
convective exchange volumes
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Apr 2017

First posted11 Aug 2016 (estimated)
Study startJul 2016
Primary completionAug 2016
Study completionApr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for ESRDStudies 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: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02863016
Sponsor's protocol ID: HEPHAESTUS_020713
Acronym: HEPHAESTUS
Status last verified: Dec 2020
First submitted: 1 Aug 2016
Last updated: 19 Dec 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.
PubMed 23411788
Panichi V., Bernabini G., Fanelli R., Rosati A., Pizzarelli F. Emodiafiltrazione (HDF) on line in post-diluizione con un nuovo concentrato acido a base di citrato: risultati di uno studio pilota multicentrico. Atti Convegno SIN, Genova, 2011
Matsuyama K, Tomo T, Kadota J. Acetate-free blood purification can impact improved nutritional status in hemodialysis patients. J Artif Organs. 2011 Jun;14(2):112-9. doi: 10.1007/s10047-010-0551-7. Epub 2011 Feb 19.
PubMed 21336818
Pizzarelli F, Cantaluppi V, Panichi V, Toccafondi A, Ferro G, Farruggio S, Grossini E, Dattolo PC, Miniello V, Migliori M, Grimaldi C, Casani A, Borzumati M, Cusinato S, Capitanini A, Quercia A, Filiberti O, Dani L; Hephaestus study group. Citrate high volume on-line hemodiafiltration modulates serum Interleukin-6 and Klotho levels: the multicenter randomized controlled study "Hephaestus". J Nephrol. 2021 Oct;34(5):1701-1710. doi: 10.1007/s40620-020-00943-6. Epub 2021 Feb 9.
PubMed 33559851

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All ESRD trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: tHe Effects of Postdilution Online Hemodiafiltration With AcEtate-free Citrate dialySis Fluid on Inflammation Markers in TUscan Prevalent Hemodialysis patientS: HEPHAESTUS Study
ClinicalTrials.gov ID: NCT02863016
Acronym / sponsor ID: HEPHAESTUS / HEPHAESTUS_020713
Conditions: ESRD
Keywords: dialysis, hemodiafiltration
Study type: Observational
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Ospedale Santa Maria AnnunziataUniversity, hospital or other
Study start: Jul 2016 (actual)
Primary completion: Aug 2016 (actual)
Study completion: Apr 2017 (actual)
First posted: 11 Aug 2016 (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.

Detailed description

The secondary objectives of this study are to evaluate if Cit-HDF, compared to Ac-HDF, can have an effect in a period of 3 months on the following aspects:

the change weekly pre-dialysis values of other markers of oxidative stress (TAC, NF-kB);
the technical parameters of HDF treatment, such as convective volumes, and blood pressure in the circuit in the filter (TMP, pressure pre-filter);
the cardiovascular stability through blood pressure and heart rate before and after dialysis (SBP, DBP, HR) and number of intradialytic hypotension;
the parameters of safety as the variation of the values of the mobility Predialytic bone (PTH, alkaline phosphatase, fetuin-A), the variation of the values intradialytic biochemical impacted by citrate (total and ionized calcium, bicarbonate) and clotting time (aPTT);
the variation of calcifications observed by:
the expression of molecules that express the ability of calcification of muscle cells and endothelial cells in culture with plasma taken at the beginning of treatment
a measure of carotid intimal thickness and pulse vawe velocity by Eco Color Doppler (optional);
dialysis efficiency by varying pre-and post-dialysis (RR%) and Clearance average molecular weight solutes with small and medium (Phosphorus, Beta2 Micro, Myoglobin) and indices of dialysis adequacy of small molecules such as EKT / V based on the dialysance ion formula Watson (calculated automatically by the monitor to dialysis);

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Concentrate SelectBag One	–	Device: SelectBag OneEach patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution: first of all concentrate SelectBag One (with 3 mM of acetic acid and 0 mM of citrate)
Concentrate SelectBag Citrate	–	Device: SelectBag OneEach patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution, then with SelectBag Citrate (with 0 mM of acetic acid and 1 mM of citric acid)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: * Patients clinically stable. * age> 18. * HDF in renal replacement therapy for more than 1 month. * good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

Key inclusion criteria (4 listed)

. Patients clinically stable.
age> 18.
HDF in renal replacement therapy for more than 1 month.
good functionality of the vascular blood flow that allows real at least 250 ml / min. and recirculation below 10%.

Key exclusion criteria (3 listed)

Life expectancy <3 months.
With residual renal function> 500 ml / day.
Vascular access with CVC

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
SelectBag OneAlso: SelectBag CitrateEach patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution with two kind of concentrates: acetic acid (Ac-HDF) and acetate-free citrate containing one (HDF-Cit ). For each of the sessions will be used online HDF postdilution with TMP biofeedback (UltraControl) and Filter high permeability.	Device	Concentrate SelectBag Citrate, Concentrate SelectBag One

Primary outcome

Inflammation
Time frame: 3 months
Value of IL-6

1 secondary outcome

Dialytic dose
Time frame: 3 months

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 19 Dec 2020.
Background: PubMed 23411788Maduell F, Moreso F, Pons M, Ramos R, Mora-Macia J, Carreras J, Soler J, Torres F, Campistol JM, Martinez-Castelao A; ESHOL Study Group. High-efficiency postdilution online hemodiafiltration reduces all-cause mortality in hemodialysis patients. J Am Soc Nephrol. 2013 Feb;24(3):487-97. doi: 10.1681/ASN.2012080875. Epub 2013 Feb 14.
BackgroundPanichi V., Bernabini G., Fanelli R., Rosati A., Pizzarelli F. Emodiafiltrazione (HDF) on line in post-diluizione con un nuovo concentrato acido a base di citrato: risultati di uno studio pilota multicentrico. Atti Convegno SIN, Genova, 2011
Background: PubMed 21336818Matsuyama K, Tomo T, Kadota J. Acetate-free blood purification can impact improved nutritional status in hemodialysis patients. J Artif Organs. 2011 Jun;14(2):112-9. doi: 10.1007/s10047-010-0551-7. Epub 2011 Feb 19.
Derived from this study: PubMed 33559851Pizzarelli F, Cantaluppi V, Panichi V, Toccafondi A, Ferro G, Farruggio S, Grossini E, Dattolo PC, Miniello V, Migliori M, Grimaldi C, Casani A, Borzumati M, Cusinato S, Capitanini A, Quercia A, Filiberti O, Dani L; Hephaestus study group. Citrate high volume on-line hemodiafiltration modulates serum Interleukin-6 and Klotho levels: the multicenter randomized controlled study "Hephaestus". J Nephrol. 2021 Oct;34(5):1701-1710. doi: 10.1007/s40620-020-00943-6. Epub 2021 Feb 9.
Individual participant dataSharing planned: No

Related trials for ESRD

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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 Pizzarelli, Dr principal investigator

Ospedale Santa Maria Annunziata_ Firenze (Italy)

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of ESRD, run by Ospedale Santa Maria Annunziata at 3 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 4 inclusion and 3 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

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?

Inflammation (time frame: 3 months). 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 NCT02863016, which also lists 4 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 19 Dec 2020.