Renal FailureSOCRATHENCT01582867
HemoControl System Activated in Hemodiafiltration Treatments
A study testing ARTIS hemodialysis system in people with Renal Failure, run by Vantive Health LLC at 1 site in Italy.
Trial summary
The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- ARTIS hemodialysis system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- May 2012to May 2013
- 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
- A subject must meet ALL of the following inclusion criteria in order to participate in this study:
- ESRD in chronic dialysis treatments for at least 3 months
- Age ≥ 18 years
- Body weight ≥ 40 kg
- Blood flow rate ≥ 250 ml/min with a recirculation of the vascular access < 5%
- Use of not fractioned heparin in continuous infusion as anticoagulant
Show all 10Show fewer
- Stable anticoagulation dosage over the last 6 treatments
- Stable dialysis prescription (Qb, Qd, treatment time) over the last 6 treatments
- Informed consent for participating to the study
- Stable Haemoglobin concentration at beginning of the treatment lower than or equal to 14 g/dl.
Who cannot join
- A subject shall NOT participate in the study if he/she meets ANY of the following criteria:
- HIV positivity
- Active Hepatitis A, B or C
- Pregnancy
- Participating in other clinical investigations during the course of this study
- Failed to release consent
Show all 14Show fewer
- Known coagulation disorders (clotting problems)
- Known bleeding risk
- Clinical or laboratory diagnosis of acute infection
- Recent (last 4 weeks) surgical intervention
- Therapy prescribed is only HD, HF or isolated UF mode
- Active phase cancer,
- Active phase immune disease.
- Serious hemostasis disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studio Cross-Over Controllato Randomizzato Sul Dispositivo ArTis Con Hemocontrol in Emodiafiltrazione - SOCRATHE
The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.
Read the detailed description
Hemodiafiltration (HDF) is a dialysis technique that allows the removal of high molecular weight toxic solutes exploiting the convective transport through the dialyzer membrane: at the same time, the HDF has a positive impact on the systemic hemodynamic, ameliorating in this way the tolerance of the treatment. Unfortunately, also the HDF therapy can be not well tolerated, introducing in the patients serious hypovolemia during the removal of the body water accumulated in the interdialytic period.
The HemoControl system, automatically controlling the relative blood volume change of the patient, avoids the onset of the hypovolemia. Today the HemoControl system can be used only during conventional hemodialysis treatments; the objective of this study is to combine the advantages of the intradialytic hemodynamic stabilization achievable by means of HemoControl with the inherent advantages, both of depurative and cardiovascular kind, typical of the Hemodiafiltration technique.
- Conditions
- Renal Failure
- Being tested
- ARTIS hemodialysis system
- Keywords
- Hemodiafiltration, Hemodialysis, Sodium, Artis, renal failure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTIS hemodialysis systemDevice
Also called Artis™ hemodialysis system, HEMOCONTROL™, GAMBRO
Software versions:
Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01
| Study group | Role | What they receive |
|---|---|---|
| HD and HDF | Experimental | During one part of the study (study phase A) patients will undergo hemodialysis (HD) treatments with Hemoscan over 2 weeks (Run-In period), followed by 12 HD sessions with HemoControl during the following 4 to 6 weeks. Separated by a one week wash out period, the same patients will be switched to On-Line Hemodiafiltration (HDF) treatments (study phase B), for a Run-In period of 2 weeks with Hemoscan, followed by 12 On-Line HDF sessions with HemoControl over the last 4 to 6 weeks of the study period. Receives: Device: ARTIS hemodialysis system |
| HDF and HD | Experimental | patients will be treated vice versa, starting with On-Line Hemodiafiltration (HDF) followed by hemodialysis (HD) with the same respective Run-In periods and a washout period as patients in Arm hemodialysis (HD) and Hemodiafiltration (HDF) . Receives: Device: ARTIS hemodialysis system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium mass balance
- to determine whether the same HemoControl prescription is usable in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments and, if not,
- to assess the existence of a proper HemoControl prescription in On-Line Hemodiafiltration (HDF) treatment.
Measured: during dialysis treatment within 18 weeks
Secondary outcomes (3)
blood pressure
difference between the pre-treatment systolic and diastolic blood pressures in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) with respect to the control treatments
Measured: Pre-dialytic within 18 weeks
thirst perception
Average difference between the thirst score reported by the patient during On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments with respect to the score reported during the control treatments
Measured: during dialysis within 18 weeks
weight gain
difference between the interdialytic weight gain in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments with respect to the control treatment
Measured: between dialysis treatments within 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Dasco S.p.A., Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Antonio Santoro, Dr., Principal investigator, POLICLINICO SANT'ORSOLA MALPIGHI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582867
- Sponsor's protocol ID
- 1495
- Acronym
- SOCRATHE
- Status last verified
- Mar 2025
- First submitted
- 16 Apr 2012
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio Cross-Over Controllato Randomizzato Sul Dispositivo ArTis Con Hemocontrol in Emodiafiltrazione - SOCRATHE
- ClinicalTrials.gov ID
- NCT01582867
- Acronym / sponsor ID
- SOCRATHE / 1495
- Conditions
- Renal Failure
- Keywords
- Hemodiafiltration, Hemodialysis, Sodium, Artis, renal failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Dasco S.p.A., Baxter Healthcare Corporation
- Study start
- May 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 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.
The current study aims to assess the HemoControl prescription in On-Line Hemodiafiltration treatment.
Detailed description
Hemodiafiltration (HDF) is a dialysis technique that allows the removal of high molecular weight toxic solutes exploiting the convective transport through the dialyzer membrane: at the same time, the HDF has a positive impact on the systemic hemodynamic, ameliorating in this way the tolerance of the treatment. Unfortunately, also the HDF therapy can be not well tolerated, introducing in the patients serious hypovolemia during the removal of the body water accumulated in the interdialytic period.
The HemoControl system, automatically controlling the relative blood volume change of the patient, avoids the onset of the hypovolemia. Today the HemoControl system can be used only during conventional hemodialysis treatments; the objective of this study is to combine the advantages of the intradialytic hemodynamic stabilization achievable by means of HemoControl with the inherent advantages, both of depurative and cardiovascular kind, typical of the Hemodiafiltration technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HD and HDF | Experimental | Device: ARTIS hemodialysis systemDuring one part of the study (study phase A) patients will undergo hemodialysis (HD) treatments with Hemoscan over 2 weeks (Run-In period), followed by 12 HD sessions with HemoControl during the following 4 to 6 weeks. Separated by a one week wash out period, the same patients will be switched to On-Line Hemodiafiltration (HDF) treatments (study phase B), for a Run-In period of 2 weeks with Hemoscan, followed by 12 On-Line HDF sessions with HemoControl over the last 4 to 6 weeks of the study period. |
| HDF and HD | Experimental | Device: ARTIS hemodialysis systempatients will be treated vice versa, starting with On-Line Hemodiafiltration (HDF) followed by hemodialysis (HD) with the same respective Run-In periods and a washout period as patients in Arm hemodialysis (HD) and Hemodiafiltration (HDF) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A subject must meet ALL of the following inclusion criteria in order to participate in this study:
Key exclusion criteria (14 listed)
- A subject shall NOT participate in the study if he/she meets ANY of the following criteria:
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 |
|---|---|---|
| ARTIS hemodialysis systemAlso: Artis™ hemodialysis system, HEMOCONTROL™, GAMBROSoftware versions: Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01 | Device | HD and HDF, HDF and HD |
Primary outcome
Sodium mass balance
Time frame: during dialysis treatment within 18 weeks
* to determine whether the same HemoControl prescription is usable in On-Line Hemodiafiltration (HDF) and hemodialysis (HD) treatments and, if not, * to assess the existence of a proper HemoControl prescription in On-Line Hemodiafiltration (HDF) treatment.
3 secondary outcomes
blood pressure
Time frame: Pre-dialytic within 18 weeks
thirst perception
Time frame: during dialysis within 18 weeks
weight gain
Time frame: between dialysis treatments within 18 weeks
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 13 Mar 2025.
Related trials for Renal Failure
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.
Antonio Santoro, Dr. principal investigator
POLICLINICO SANT'ORSOLA MALPIGHI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTIS hemodialysis system in people with Renal Failure, run by Vantive Health LLC at 1 site 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 10 inclusion and 14 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Sodium mass balance (time frame: during dialysis treatment within 18 weeks). 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 13 Mar 2025.