NCT01539252

Brief Summary

The purpose of this study is to investigate the effectiveness of using two dialysers to lower the blood mineral levels in people receiving hemodialysis as compared to using one dialyser (usual treatment).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 8, 2016

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

February 3, 2012

Last Update Submit

December 7, 2016

Conditions

End Stage Renal Disease

Keywords

hemodialysisadequacyphosphate clearancedouble dialyzertwo dialyzers in parallel

Outcome Measures

Primary Outcomes (1)

  • Dialysate clearance of phosphate

    Dialysate phosphate clearance levels in double dialyzer periods compared to single dialyzer periods.

    3 weeks

Secondary Outcomes (2)

  • Serum phosphate

    3 weeks

  • Dialysate removal of phosphate

    3 weeks

Other Outcomes (2)

  • Proportion of participants with serious adverse events

    30 days following last day of intervention

  • Proportion of participants with adverse events

    30 days following last day of intervention

Study Arms (2)

Single dialyzer

ACTIVE COMPARATOR

Single dialyzer

Procedure: Single dialyzer

Double dialyzer

EXPERIMENTAL

Two dialyzers in parallel

Procedure: Two dialyzers

Interventions

Single dialyzerPROCEDURE

Hemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment.

Single dialyzer
Two dialyzersPROCEDURE

Hemodialysis treatment using a two Baxter dialyzers in parallel.

Double dialyzer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Patients must be on a stable regimen of hemodialysis for ≥ 3 months ('stable' defined as not expected to require a change to the duration or frequency of treatments)
  • Serum phosphate \> 1.6 mmol/l on last two consecutive lab tests at least 3 weeks apart (KDOQI guidelines recommend maintaining predialysis phosphate \< 1.8mmol/l - as such, phosphate lowering in this subgroup of patients is particularly relevant)
  • Patients must be on stable doses of a phosphate binder with no changes in dose 1 month prior to study enrolment.
  • Blood flow rate ≥ 350 ml/min through a well-functioning access (This will exclude patients receiving inadequate dialysis due to a temporary venous dialysis catheter and will ensure sufficient blood flow to permit dialysis using two dialysers in parallel.)

You may not qualify if:

  • Patients who have a scheduled renal transplant, change in dialysis modality, surgery or hospitalization or plan on moving away from the study site in the next three months.
  • Patients with a projected life expectancy of less than 3 months.
  • Patients with a contraindication to intra-dialytic anticoagulation. (Some patients require a small increase in the amount of anticoagulation required to prevent dialyser clotting when using two dialysers in parallel).
  • Patients who have missed \>8 dialysis treatments in the past 3 months.
  • Patients with a dialysis regimen of \>3 runs per week.
  • Failure to provide informed consent.
  • Patients enrolled in another (interventional) trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta

Edmonton, Alberta, T6G 2V2, Canada

Location

Related Publications (1)

  • Thompson S, Manns B, Lloyd A, Hemmelgarn B, MacRae J, Klarenbach S, Unsworth L, Courtney M, Tonelli M. Impact of using two dialyzers in parallel on phosphate clearance in hemodialysis patients: a randomized trial. Nephrol Dial Transplant. 2017 May 1;32(5):855-861. doi: 10.1093/ndt/gfw085.

    PMID: 27190374RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marcello Tonelli, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

  • Braden Manns, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 27, 2012

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

December 8, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)