Mid-HDF Randomized Controlled Study on Outcome (MILESTONE)

January 12, 2017 updated by: Antonio Santoro, IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 3000
        • Cliniques Universitaires Saint-Luc
  • France
      • Marseille, France, 13385
        • Hôpital de la Conception
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero-Universitaria di Bologna
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Inclusion to other studies
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HF dialysis
HF (high-flux) dialysis is standard hemodialysis treatment performed by using a high permeability dialyzer instead of a low permeability one.
Device: HF dialysis
Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes
Other Names:
  • PHYLTHER HF
  • DIAPES HF
Experimental: Mid-dilution HDF
Mid-dilution is a newly developed hemodiafiltration therapy able to allow a simultaneous pre- and post-dilution infusion.
Device: Mid-dilution HDF
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
Other Names:
  • OLPUR MD 220
  • OLPUR MD 190

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
crude, all-causes mortality
Time Frame: 5 years
The primary objective will be assessed by the incidence rate of fatal events
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular morbidity
Time Frame: 5 years

It will be assessed by taking into consideration:

  • Number of hospital admissions related to non fatal major CV events
  • Length of stay during hospitalization
5 years
Quality of life and dialysis tolerance evaluated by questionnaire
Time Frame: 1 year

It will be assessed by taking into consideration:

- Results of the SF-36 questionnaire given to the patients
1 year
Micro-inflammation evaluation
Time Frame: 1 year

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
1 year
Nutrition and anaemia management
Time Frame: 1 year

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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Study Chair: Francisco Maduell, MD, Hospital Clinic Barcelona, Spain
  • Study Chair: Vincenzo Panichi, MD, PhD, AUSL 12 Viareggio, Italy
  • Study Chair: Pedro Aljama, MD, PhD, Hospital Reina Sofia, Cordoba, Spain
  • Study Chair: Michel Jadoul, MD, PhD, Cliniques Universitaires Saint-Luc, Brussels, Belgium
  • Study Chair: Philippe Brunet, MD, PhD, Hôpital de la Conception, Marseille, France
  • Study Chair: Antonio Santoro, MD, AOSP Bologna, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 6, 2012

First Submitted That Met QC Criteria

September 24, 2012

First Posted (Estimate)

September 26, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MID-INT01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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