End Stage Renal Disease on DialysisNCT04360694
RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis (REAL-LIFE)
A study testing Incremental hemodialysis and Conventional hemodialysis in people with End Stage Renal Disease on Dialysis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- Incremental hemodialysis and Conventional hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged > 18 years
- Start of maintenance hemodialysis treatment due to advanced CKD stage 5D
- Patients who are about to start HD or have already started HD within a period of ≤ 2 weeks
- Glomerular filtration rate <= 10 mL/min/1.73 m2, as estimated by means of CKD-EPI formula.
Who cannot join
- Age < 18 years
- Acute kidney injury or acute on chronic kidney injury
- eGFR higher than 10 mL/min/1.73 m2
- UO < 600 mL/day
- Already treated with other replacement therapies (peritoneal dialysis or kidney transplant)
- Unable or unwilling to give informed consent.
Show all 10Show fewer
- Unable to comply with trial procedures, e.g., collection of UO.
- Likely survival prognosis or planned modality or centre transfer < 6 months.
- Patients who are in the waiting list for a living kidney transplant
- Associated diseases: active neoplastic disease; refractory congestive heart failure (type IV NYHA, ejection fraction ≤ 30%) requiring high ultrafiltration volumes per session.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Consorziale Policlinico
Bari, 70124
Loreto Gesualdo, +390805594041, loreto.gesualdo@uniba.it
Domenico Roselli, +390805592778, domenico.roselli@policlinico.ba.it
About this study
Official title: RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis
Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed.
Methods/Design:
Read more
The Department of Nephrology, Dialysis and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is "REAL LIFE", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness.
Discussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.
Read the detailed description
The majority of dialysis patients starting hemodialysis (HD) are currently treated with a fixed dose thrice-weekly HD (3HD/wk). The 3HD/wk regimen has been assumed, until recently, almost as a dogma in the dialysis community. Incremental HD is based on the simple idea of adjusting its dose according to the metrics of RKF. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). A Variable Target Model (VTM) has been suggested, which gives more clinical weight to the RKF and allows less frequent HD treatments in patients with lower RKF. The investigators recommend to start and keep on with once-weekly HD, which should be possible until residual renal urea clearance (KRU) falls below 2.5 - 3.0 mL/min/35 L, i.e., glomerular filtration rate (GFR) ≈ 4 mL/min/1.73 m2.
The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness. Secondary outcomes are: composite primary cardiovascular endpoint (cardiovascular death, non fatal myocardial infarction and/or or non fatal stroke); intima-media thickness of the carotid arteries; specific cardiomyopathy control; RKF preservation; patients survival; hospital admissions; anemia control; mineral and bone disorder control, and middle molecules removal.
The sample size calculation is based on the primary outcome "presence of anuria". The assumptions for calculating the sample size, derived from data of Teruel Briones et al., are the following:
- Percentage of subjects who developed anuria in the experimental group (incremental HD): 25%
- Percentage of subjects who developed anuria in the control group (standard 3HD/wk): 51%
- Power: 0.8
- Ratio: 1:1
- Non-compliance: 20%
- Total expected sample size: 190 (95 participants in each group)
The assessment of the key kinetic parameters as well as the guide to the selection of operative parameters, as required to get the required equilibrated Kt/V (eKt/V = 1.05), will be done by using SPEEDY, a spreadsheet prescription tool that uses essentially the same equations used by Solute Solver, the software based on the double pool UKM recommended by the 2015 KDOQI guidelines. SPEEDY is freely available at the European Nephrology Portal (ENP).
The link is https://enp-era-edta.org/174/page/home. The control arm includes patients put on a thrice-weekly HD schedule, as detailed above. The dialysis dose (eKt/V) should be about 1.05.
PICO question:
Participants with CKD-EPI GFR ≤ 10 ml/min and daily urine output > 600 ml Intervention: one or two weekly hemodialysis (as detailed above) Comparator: three weekly hemodialysis (as per standard practice and as detailed above) Outcome: Residual renal function
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- Incremental hemodialysis, Conventional hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incremental hemodialysisProcedure or surgery
95 patients will start renal replacement therapy (RRT) with an incremental hemodialysis (once-weekly or twice-weekly) regimen.
Conventional hemodialysisProcedure or surgery
95 patients will start renal replacement therapy (RRT) with the standard (thrice-weekly) hemodialysis regimen.
| Study group | Role | What they receive |
|---|---|---|
| Incremental hemodialysis | Experimental | Procedure: Incremental hemodialysis. It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression Receives: Procedure: Incremental hemodialysis |
| Conventional hemodialysis | Active comparator | Procedure: Conventional hemodialysis. It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group). Receives: Procedure: Conventional hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants whose kidney function remains >200 ml
The survival of kidney function is defined as a time to the event (anuria): the anuria is defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness
Measured: 24 months
Secondary outcomes (10)
Number of participants who develop cardiovascular death, non fatal myocardial infarction and/or or non fatal stroke (composite outcome)
Cardiovascular death, non fatal myocardial infarction and/or or non fatal stroke
Measured: 24 months
Mean value of intima-media thickness of the carotid arteries of participants at end of treatment and change from beginning to end of treatment
Echographic evaluation of intima-media thickness of the carotid arteries
Measured: 12 and 24 months
Value of left ventricular ejection fraction established with cardiac ultrasound at end of treatment and change from beginning to end of treatment
Ecocardiography reporting data on the left ventricular ejection fraction (LVEF)
Measured: 12 and 24 months
Value of residual kidney function (RKF) preservation established by the slope of decline of residual renal urea clearance
The rate of decline in RKF defined as the slope of decline of residual renal urea clearance
Measured: 24 months
Number of people who die
The follow-up time will be determined in days. It will be defined as the difference in days from the date of the end of the follow-up minus the date of the baseline visit. Events will be counted either as deaths (follow-up of less than 24 months) or as end of the follow-up
Measured: 24 months
Number of people who are hospitalized
The number of admissions will be registered.
Measured: 24 months
Value of hemoglobin in participants at end of treatment and change from beginning to end of treatment
The hemoglobin levels (in g/dl) will be measured.
Measured: Every month
Value of serum phosphorus, calcium and parathyroid hormone in participants at end of treatment and change from beginning to end of treatment
Serum phosphorus and calcium levels (in mg/dl), and intact PTH (in pg/dl) will be measured.
Measured: Every month and three months
Value of serum beta 2 microglobulin (middle molecule) at end of treatment and change from beginning to end of treatment
The rate of change in serum beta 2 microglobulin in time will be evaluated
Measured: Every three months
Value of p-cresyl sulfate and inoxyl sulfate at end of treatment and change from beginning to end of treatment (uraemic toxins variation)
Variation of uremic toxins including p-cresyl sulfate and inoxyl sulfate
Measured: Every six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start10 May 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies 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
- Parallel groups
- Model description
- REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). It consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The investigators recommend to start and keep on with once-weekly HD, which should be possible until residual renal urea clearance (KRU) falls below 2.5 - 3.0 mL/min/35 L, i.e., glomerular filtration rate (GFR) ≈ 4 mL/min/1.73 m2. Then, HD sessions will be increased to twice-weekly. When KRU falls bellow 1.5 ml/min/35L, dialysis schedule will change to thrice-weekly, as per criteria for progression. It is controlled through usual clinical practice.
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- European Renal Association - European Dialysis and Transplant Association
- Responsible party
- Principal investigator, Loreto Gesualdo, MD, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360694
- Sponsor's protocol ID
- REAL LIFE
- Status last verified
- Jun 2024
- First submitted
- 17 Apr 2020
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Casino FG, Basile C. The variable target model: a paradigm shift in the incremental haemodialysis prescription. Nephrol Dial Transplant. 2017 Jan 1;32(1):182-190. doi: 10.1093/ndt/gfw339.
PubMed 27742823Basile C, Casino FG, Kalantar-Zadeh K. Is incremental hemodialysis ready to return on the scene? From empiricism to kinetic modelling. J Nephrol. 2017 Aug;30(4):521-529. doi: 10.1007/s40620-017-0391-0. Epub 2017 Mar 23.
PubMed 28337715Basile C, Casino FG; EUDIAL Working Group of ERA-EDTA. Incremental haemodialysis and residual kidney function: more and more observations but no trials. Nephrol Dial Transplant. 2019 Nov 1;34(11):1806-1811. doi: 10.1093/ndt/gfz035. No abstract available.
PubMed 30805639Casino FG, Basile C. A user-friendly tool for incremental haemodialysis prescription. Nephrol Dial Transplant. 2018 Jun 1;33(6):1074-1075. doi: 10.1093/ndt/gfy081. No abstract available.
PubMed 29672745Casino FG, Lopez T. The equivalent renal urea clearance: a new parameter to assess dialysis dose. Nephrol Dial Transplant. 1996 Aug;11(8):1574-81.
PubMed 8856214Teruel-Briones JL, Fernandez-Lucas M, Rivera-Gorrin M, Ruiz-Roso G, Diaz-Dominguez M, Rodriguez-Mendiola N, Quereda-Rodriguez-Navarro C. Progression of residual renal function with an increase in dialysis: haemodialysis versus peritoneal dialysis. Nefrologia. 2013;33(5):640-9. doi: 10.3265/Nefrologia.pre2013.May.12038. English, Spanish.
PubMed 24089155
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RandomizEd ClinicAL triaL on the Efficacy and saFety of Incremental Hemodialysis
- ClinicalTrials.gov ID
- NCT04360694
- Acronym / sponsor ID
- REAL LIFE
- Conditions
- End Stage Renal Disease on Dialysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- European Renal Association - European Dialysis and Transplant Association
- Study start
- 10 May 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Apr 2020 (actual)
- 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.
Background: The thrice-weekly hemodialysis (HD) regimen is widely accepted as a standard prescription. The concept of incremental dialysis has been established as a possible alternative for patients with preserved diuresis and end-stage renal failure in need of HD. The main problems related to prescription of incremental HD are an arbitrary use of infrequent regimens and the lack of clear standards for incorporating residual kidney function (RKF) in the assessment of HD dose. Several models have been proposed for prescription of incremental dialysis. The latest, the variable target model (VTM), gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF. Despite increasing evidence derived from observational studies to support the use of incremental HD, RCTs are lacking and, therefore, urgently needed.
Methods/Design:
The Department of Nephrology, Dialysis and Transplantation of the Azienda Ospedaliero Universitaria Consorziale Policlinico, Bari, Italy and the EUDIAL Working Group of the European Renal Association - European Dialysis Transplant Association (ERA-EDTA) are starting a randomized clinical trial (RCT) in incident HD patients, whose name is "REAL LIFE", by using the acronym of its whole definition: RandomizEd clinicAL triaL on the effIcacy and saFety of incremental haEmodialysis. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). The trial, originally conceived by experts at the Division of Nephrology of the Miulli General Hospital, Acquaviva delle Fonti, Italy, consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness.
Discussion: REAL LIFE will enable the investigators to know with the highest level of scientific evidence the safety and efficacy of an incremental approach to the start of HD treatment.
Detailed description
The majority of dialysis patients starting hemodialysis (HD) are currently treated with a fixed dose thrice-weekly HD (3HD/wk). The 3HD/wk regimen has been assumed, until recently, almost as a dogma in the dialysis community. Incremental HD is based on the simple idea of adjusting its dose according to the metrics of RKF. REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). A Variable Target Model (VTM) has been suggested, which gives more clinical weight to the RKF and allows less frequent HD treatments in patients with lower RKF. The investigators recommend to start and keep on with once-weekly HD, which should be possible until residual renal urea clearance (KRU) falls below 2.5 - 3.0 mL/min/35 L, i.e., glomerular filtration rate (GFR) ≈ 4 mL/min/1.73 m2.
The primary outcome is the survival of kidney function, with the event defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness. Secondary outcomes are: composite primary cardiovascular endpoint (cardiovascular death, non fatal myocardial infarction and/or or non fatal stroke); intima-media thickness of the carotid arteries; specific cardiomyopathy control; RKF preservation; patients survival; hospital admissions; anemia control; mineral and bone disorder control, and middle molecules removal.
The sample size calculation is based on the primary outcome "presence of anuria". The assumptions for calculating the sample size, derived from data of Teruel Briones et al., are the following:
- Percentage of subjects who developed anuria in the experimental group (incremental HD): 25%
- Percentage of subjects who developed anuria in the control group (standard 3HD/wk): 51%
- Power: 0.8
- Ratio: 1:1
- Non-compliance: 20%
- Total expected sample size: 190 (95 participants in each group)
The assessment of the key kinetic parameters as well as the guide to the selection of operative parameters, as required to get the required equilibrated Kt/V (eKt/V = 1.05), will be done by using SPEEDY, a spreadsheet prescription tool that uses essentially the same equations used by Solute Solver, the software based on the double pool UKM recommended by the 2015 KDOQI guidelines. SPEEDY is freely available at the European Nephrology Portal (ENP).
The link is https://enp-era-edta.org/174/page/home. The control arm includes patients put on a thrice-weekly HD schedule, as detailed above. The dialysis dose (eKt/V) should be about 1.05.
PICO question:
Participants with CKD-EPI GFR ≤ 10 ml/min and daily urine output > 600 ml Intervention: one or two weekly hemodialysis (as detailed above) Comparator: three weekly hemodialysis (as per standard practice and as detailed above) Outcome: Residual renal function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- REAL LIFE is a pragmatic, prospective, multicentre, open label RCT, investigator-initiated, comparing the intervention arm (incremental HD) with the control arm (standard 3HD/wk). It consists in starting the HD treatment adopting the new incremental approach guided by the VTM. The investigators recommend to start and keep on with once-weekly HD, which should be possible until residual renal urea clearance (KRU) falls below 2.5 - 3.0 mL/min/35 L, i.e., glomerular filtration rate (GFR) ≈ 4 mL/min/1.73 m2. Then, HD sessions will be increased to twice-weekly. When KRU falls bellow 1.5 ml/min/35L, dialysis schedule will change to thrice-weekly, as per criteria for progression. It is controlled through usual clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Incremental hemodialysis | Experimental | Procedure: Incremental hemodialysisProcedure: Incremental hemodialysis. It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression |
| Conventional hemodialysis | Active comparator | Procedure: Conventional hemodialysisProcedure: Conventional hemodialysis. It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged > 18 years
- Start of maintenance hemodialysis treatment due to advanced CKD stage 5D
- Patients who are about to start HD or have already started HD within a period of ≤ 2 weeks
- Glomerular filtration rate <= 10 mL/min/1.73 m2, as estimated by means of CKD-EPI formula.
Key exclusion criteria (10 listed)
- Age < 18 years
- Acute kidney injury or acute on chronic kidney injury
- eGFR higher than 10 mL/min/1.73 m2
- UO < 600 mL/day
- Already treated with other replacement therapies (peritoneal dialysis or kidney transplant)
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 |
|---|---|---|
| Incremental hemodialysis95 patients will start renal replacement therapy (RRT) with an incremental hemodialysis (once-weekly or twice-weekly) regimen. | Procedure or surgery | Incremental hemodialysis |
| Conventional hemodialysis95 patients will start renal replacement therapy (RRT) with the standard (thrice-weekly) hemodialysis regimen. | Procedure or surgery | Conventional hemodialysis |
Primary outcome
Number of participants whose kidney function remains >200 ml
Time frame: 24 months
The survival of kidney function is defined as a time to the event (anuria): the anuria is defined as urinary output (UO) ≤ 200 mL/day, confirmed by a further collection after 2 weeks to exclude temporary illness
10 secondary outcomes
Number of participants who develop cardiovascular death, non fatal myocardial infarction and/or or non fatal stroke (composite outcome)
Time frame: 24 months
Mean value of intima-media thickness of the carotid arteries of participants at end of treatment and change from beginning to end of treatment
Time frame: 12 and 24 months
Value of left ventricular ejection fraction established with cardiac ultrasound at end of treatment and change from beginning to end of treatment
Time frame: 12 and 24 months
Value of residual kidney function (RKF) preservation established by the slope of decline of residual renal urea clearance
Time frame: 24 months
Number of people who die
Time frame: 24 months
Number of people who are hospitalized
Time frame: 24 months
Value of hemoglobin in participants at end of treatment and change from beginning to end of treatment
Time frame: Every month
Value of serum phosphorus, calcium and parathyroid hormone in participants at end of treatment and change from beginning to end of treatment
Time frame: Every month and three months
Value of serum beta 2 microglobulin (middle molecule) at end of treatment and change from beginning to end of treatment
Time frame: Every three months
Value of p-cresyl sulfate and inoxyl sulfate at end of treatment and change from beginning to end of treatment (uraemic toxins variation)
Time frame: Every six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Results publication: PubMed 27742823Casino FG, Basile C. The variable target model: a paradigm shift in the incremental haemodialysis prescription. Nephrol Dial Transplant. 2017 Jan 1;32(1):182-190. doi: 10.1093/ndt/gfw339.
- Results publication: PubMed 28337715Basile C, Casino FG, Kalantar-Zadeh K. Is incremental hemodialysis ready to return on the scene? From empiricism to kinetic modelling. J Nephrol. 2017 Aug;30(4):521-529. doi: 10.1007/s40620-017-0391-0. Epub 2017 Mar 23.
- Results publication: PubMed 30805639Basile C, Casino FG; EUDIAL Working Group of ERA-EDTA. Incremental haemodialysis and residual kidney function: more and more observations but no trials. Nephrol Dial Transplant. 2019 Nov 1;34(11):1806-1811. doi: 10.1093/ndt/gfz035. No abstract available.
- Results publication: PubMed 29672745Casino FG, Basile C. A user-friendly tool for incremental haemodialysis prescription. Nephrol Dial Transplant. 2018 Jun 1;33(6):1074-1075. doi: 10.1093/ndt/gfy081. No abstract available.
- Results publication: PubMed 8856214Casino FG, Lopez T. The equivalent renal urea clearance: a new parameter to assess dialysis dose. Nephrol Dial Transplant. 1996 Aug;11(8):1574-81.
- Results publication: PubMed 24089155Teruel-Briones JL, Fernandez-Lucas M, Rivera-Gorrin M, Ruiz-Roso G, Diaz-Dominguez M, Rodriguez-Mendiola N, Quereda-Rodriguez-Navarro C. Progression of residual renal function with an increase in dialysis: haemodialysis versus peritoneal dialysis. Nefrologia. 2013;33(5):640-9. doi: 10.3265/Nefrologia.pre2013.May.12038. English, Spanish.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incremental hemodialysis and Conventional hemodialysis in people with End Stage Renal Disease on Dialysis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 12 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Loreto Gesualdo, MD (+390805594041, loreto.gesualdo@uniba.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants whose kidney function remains >200 ml (time frame: 24 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 NCT04360694, which also lists 6 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 12 Jun 2024.