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

• ClinicalTrials.gov Identifier: NCT02374372
• Recruitment Status: Completed
• First Posted: February 27, 2015
• Last Update Posted: December 8, 2022
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Information provided by (Responsible Party): Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information

• First Submitted Date: September 24, 2013
• First Posted Date: February 27, 2015
• Last Update Posted Date: December 8, 2022
• Study Start Date: January 2011
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 26, 2015)

• compare the medication cost between the 2 groups (HD and HDF) [ Time Frame: 3 years ]
• demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group [ Time Frame: 3 years ]
• demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group [ Time Frame: 3 years ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 26, 2015)

• demonstrate lower need of Erythropoietin and best control of anemia in HDF [ Time Frame: 3 years ]
• demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF [ Time Frame: 3 years ]
• demonstrate less hospitalization stay and cost related in HDF group [ Time Frame: 3 years ]
• stabilisation or regression of left ventricular hypertrophy [ Time Frame: 3 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit
• Official Title: Prospective Randomized Study Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Chronic Renal Failure
• Hemodialysis

Intervention

• Device: conventional hemodialysis
• Device: hemodiafiltration On-line

Study Arms

• Active Comparator: conventional hemodialysis
  conventional hemodialysis
  Intervention: Device: conventional hemodialysis
• Active Comparator: hemodiafiltration On-line
  hemodiafiltration On-line
  Intervention: Device: hemodiafiltration On-line

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2017): 140
• Original Estimated Enrollment (submitted: February 26, 2015): 150
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02374372
• Other Study ID Numbers: CE10.253
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre hospitalier de l'Université de Montréal (CHUM)
• Verification Date: December 2022