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Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit (PHARMACO-$)

Primary Purpose

Chronic Renal Failure, Hemodialysis

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

conventional hemodialysis

hemodiafiltration On-line

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring hemodialysis, beta microglobulin, amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

more than 18 years old,
able to consent,
patient needs to be on hemodialysis more than 8-12 hours a week (2-3 sessions)

Exclusion Criteria:

severe none compliance (often missing sessions without good reasons),
life expectation less than 3 months,
treated with high-flux filters in the last 6 months

Sites / Locations

Centre hospitalier Universitaire de Montréal (CHUM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

conventional hemodialysis

hemodiafiltration On-line

Arm Description

conventional hemodialysis

hemodiafiltration On-line

Outcomes

Primary Outcome Measures

compare the medication cost between the 2 groups (HD and HDF)

demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group

demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group

Secondary Outcome Measures

demonstrate lower need of Erythropoietin and best control of anemia in HDF

demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF

demonstrate less hospitalization stay and cost related in HDF group

stabilisation or regression of left ventricular hypertrophy

Full Information

NCT ID

NCT02374372

First Posted

September 24, 2013

Last Updated

December 6, 2022

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

1. Study Identification

Unique Protocol Identification Number

NCT02374372

Brief Title

Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit

Acronym

PHARMACO-$

Official Title

Prospective Randomized Study Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM. This is a prospective randomized study that will compare the two treatment modalities, HD and HDF, through economics and pharmaco-economics parameters. Patients, who had previously been randomized in the CONTRAST study, will remain in their respective group and monitoring will continue. The next patients will be randomized in the same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients will receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare cases, HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to be avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min). Length and frequency of sessions will be the same in the 2 groups. Blood tests will not change and will be the same than those used as routine assessments. Metabolic control of patients will be maintained according to the guidelines. Patients will be monitored for a minimum of 3 years. A set of demographic and clinical data will be collected from patient medical records and throughout the study. Biochemical data as part of the usual blood tests of dialysis patients will be collected each month as well as will be stored and analyzed information about the annual cardiac ultrasounds. All events will be scored (hospitalizations, patterns, duration) and the list and cost of drugs will be compiled every three months. These data will be useful in the economic analysis comparing the two treatment modalities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Renal Failure, Hemodialysis

Keywords

hemodialysis, beta microglobulin, amyloidosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

conventional hemodialysis

Arm Type

Active Comparator

Arm Description

conventional hemodialysis

Arm Title

hemodiafiltration On-line

Arm Type

Active Comparator

Arm Description

hemodiafiltration On-line

Intervention Type

Device

Intervention Name(s)

conventional hemodialysis

Intervention Type

Device

Intervention Name(s)

hemodiafiltration On-line

Primary Outcome Measure Information:

Title

compare the medication cost between the 2 groups (HD and HDF)

Time Frame

3 years

Title

demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group

Time Frame

3 years

Title

demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group

Time Frame

3 years

Secondary Outcome Measure Information:

Title

demonstrate lower need of Erythropoietin and best control of anemia in HDF

Time Frame

3 years

Title

demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF

Time Frame

3 years

Title

demonstrate less hospitalization stay and cost related in HDF group

Time Frame

3 years

Title

stabilisation or regression of left ventricular hypertrophy

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: more than 18 years old, able to consent, patient needs to be on hemodialysis more than 8-12 hours a week (2-3 sessions) Exclusion Criteria: severe none compliance (often missing sessions without good reasons), life expectation less than 3 months, treated with high-flux filters in the last 6 months

Facility Information:

Facility Name

Centre hospitalier Universitaire de Montréal (CHUM)

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 3J4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit

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