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End Stage Renal DiseaseMILESTONENCT01693354

Mid-HDF Randomized Controlled Study on Outcome

A study testing Mid-dilution HDF and HF dialysis in people with End Stage Renal Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective in the reduction of the crude mortality risk in patients who have been undergoing renal replacement treatment for less than 1 year. 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?
Mid-dilution HDF and HF dialysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
4 sitesin 4 countries
Study dates
Sep 2012to Sep 2018
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

  • On a thrice/week RRT for at least 3 months
  • Dialysis vintage > 3 months
  • Signed informed consent
  • Blood flow > 300 mL/min
  • Pregnancy

Who cannot join

  • On waiting list for living-donor transplant
  • Residual diuresis > 500 mL/day
  • Inability, as judget by the investigator, to follow or understand the protocol instructions
  • Active neoplastic disease
  • Single needle treatment
  • Patients with expectancy life lower than 6 months

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Belgium1 site

  • Cliniques Universitaires Saint-Luc

    Brussels, 3000

Other trials in Belgium

France1 site

  • Hôpital de la Conception

    Marseille, 13385

Other trials in France

Italy1 site

  • Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

Other trials in Italy

Spain1 site

  • Hospital Clínic Barcelona

    Barcelona, 08036

Other trials in Spain

About this study

Official title: Mid-dilution Hemodiafiltration International Randomized Prospective Study on Incident Patients Focused on Outcome

The purpose of this study is to determine whether mid-dilution hemodiafiltration is effective in the reduction of the crude mortality risk in patients who have been undergoing renal replacement treatment for less than 1 year. Patients will be randomized since the beginning of the study in two groups: standard HF dialysis and mid-dilution HDF.

Read the detailed description

It is a matter of fact that in the last decades the Chronic Kidney Disease (CKD) population has widely changed. In Italy, for example, more than 50% of the incident dialysis patients are more than 70 year old, with diabetic and hypertension being the major underlying diseases; moreover a great percentage of the patients starts dialysis with a burden of at least 1-2 comorbidities [1]. Online hemodiafiltration (online HDF) has been recently associated with better patient survival in comparison with standard hemodialysis in two large trials [2,3]; the overall relative risk of mortality was found to be approximately 33% lower in patients treated with online HDF [2,3]. These impressive results were not obtained anyway on the whole population, but in a sub-group analysis. A strong correlation was found between the total convective volume obtained and the mortality risk reduction; HDF was found to be significantly better than standard hemodialysis when a total convective volume of 19-22 L/session (in 4 hours sessions of post-dilution HDF) was achieved.

These results support the importance of the "adequate convective dose" concept in order to improve the patient outcomes especially in frail patients, as recently demonstrated by a large randomised control trial, the MPO study [4], comparing High Flux versus Low Flux dialysis in patients with plasma albumin levels equal to or less than 4 gr/dl ( as a marker of patient comorbidities) and, in a post hoc analysis, in diabetic patients [4].

Mid-dilution HDF is a variant of classical HDF combining simultaneous pre- and post.-dilution in order to maximise middle and large solutes removal.

The MILESTONE study would aim to fully demonstrate for mid-dilution HDF the significant mortality risk reduction observed in the recent mentioned studies.

Being tested
Mid-dilution HDF, HF dialysis
Keywords
dialysis, mortality, cardiovascular stability, inflammation, quality of life
Medical subject headings
Kidney Failure, Chronic, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mid-dilution HDFDevice

    Also called OLPUR MD 220, OLPUR MD 190

    Mid-dilution HDF is a special, newly developed variant of online HDF which is characterized by a dedicated high-flux hemodialyzer named OLPUR MD able to support simultaneous pre- and post-dilution

  • HF dialysisDevice

    Also called PHYLTHER HF, DIAPES HF

    Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes

Study groups in NCT01693354
Study groupRoleWhat they receive
HF dialysisActive comparatorHF (high-flux) dialysis is standard hemodialysis treatment performed by using a high permeability dialyzer instead of a low permeability one.
Receives: Device: HF dialysis
Mid-dilution HDFExperimentalMid-dilution is a newly developed hemodiafiltration therapy able to allow a simultaneous pre- and post-dilution infusion.
Receives: Device: Mid-dilution HDF

What is being measured

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

  1. crude, all-causes mortality

    The primary objective will be assessed by the incidence rate of fatal events

    Measured: 5 years

Secondary outcomes (4)

  1. Cardiovascular morbidity

    It will be assessed by taking into consideration:

    • Number of hospital admissions related to non fatal major CV events
    • Length of stay during hospitalization

    Measured: 5 years

  2. Quality of life and dialysis tolerance evaluated by questionnaire

    It will be assessed by taking into consideration:

    • Results of the SF-36 questionnaire given to the patients

    Measured: 1 year

  3. Micro-inflammation evaluation

    It will be assessed by measuring the pre-dialysis serum levels of:

    IL-6 CR Myoglobin RbP p-cresylsulfate beta2-microglobulin.

    The hospitals' laboratories will be in charge for the sample collection and analysis

    Measured: 1 year

  4. Nutrition and anaemia management

    It will be assessed by taking in consideration the pre-dialysis serum levels of:

    Hb albumin iron.

    ESAs and iron supplementation will be as well noted in apposite CRF.

    Measured: 1 year

Timeline

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

  1. First posted26 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionSep 2017 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

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
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01693354
Sponsor's protocol ID
MID-INT01
Acronym
MILESTONE
Status last verified
Jan 2017
First submitted
6 Sep 2012
Last updated
13 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Stel VS, van de Luijtgaarden MW, Wanner C, Jager KJ; on behalf of the European Renal Registry Investigators. The 2008 ERA-EDTA Registry Annual Report-a precis. NDT Plus. 2011 Feb;4(1):1-13. doi: 10.1093/ndtplus/sfq191. Epub 2010 Nov 19.

    PubMed 21245934

  • Grooteman MP, van den Dorpel MA, Bots ML, Penne EL, van der Weerd NC, Mazairac AH, den Hoedt CH, van der Tweel I, Levesque R, Nube MJ, ter Wee PM, Blankestijn PJ; CONTRAST Investigators. Effect of online hemodiafiltration on all-cause mortality and cardiovascular outcomes. J Am Soc Nephrol. 2012 Jun;23(6):1087-96. doi: 10.1681/ASN.2011121140. Epub 2012 Apr 26.

    PubMed 22539829

  • Canaud B, Bragg-Gresham JL, Marshall MR, Desmeules S, Gillespie BW, Depner T, Klassen P, Port FK. Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS. Kidney Int. 2006 Jun;69(11):2087-93. doi: 10.1038/sj.ki.5000447.

    PubMed 16641921

  • Locatelli F, Martin-Malo A, Hannedouche T, Loureiro A, Papadimitriou M, Wizemann V, Jacobson SH, Czekalski S, Ronco C, Vanholder R; Membrane Permeability Outcome (MPO) Study Group. Effect of membrane permeability on survival of hemodialysis patients. J Am Soc Nephrol. 2009 Mar;20(3):645-54. doi: 10.1681/ASN.2008060590. Epub 2008 Dec 17.

    PubMed 19092122

Questions about this trial

What is this clinical trial studying?

A study testing Mid-dilution HDF and HF dialysis in people with End Stage Renal Disease, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in 4 countries.

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 6 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 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, France, Italy, Spain. 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?

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?

crude, all-causes mortality (time frame: 5 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 NCT01693354, 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 13 Jan 2017; AzTrials last refreshed its copy on 30 Oct 2026.

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