Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients - Full Text View

Purpose

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).

Condition	Intervention	Phase
End Stage Renal Disease	Procedure: Standard treatment Procedure: Two dialyzers	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Change in dialysate clearance of phosphate [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
Change from baseline dialysate phosphate clearance levels at the end of the single dialyzer treatment period.
Change in dialysate clearance of phosphate [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
Change from baseline dialysate phosphate clearance levels at the end of the double dialyzer treatment period.
Change in dialysate clearance of phosphate [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline dialysate phosphate clearance levels at the end of the single dialyzer treatment period.
Change in dialysate clearance of phosphate [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline dialysate phosphate clearance levels at the end of the double dialyzer treatment period.

Secondary Outcome Measures:

Change in serum phosphate [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
Change from baseline serum phosphate levels at end of single dialyzer study treatment
Change in serum phosphate [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
Change from baseline serum phosphate levels at end of double dialyzer study treatment
Change in serum phosphate [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline serum phosphate levels at end of single dialyzer study treatment
Change in serum phosphate [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline serum phosphate levels at end of double dialyzer study treatment
Change in dialysate removal of phosphate [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
Change from baseline dialysate removal levels at end of single dialyzer treatment period.
Change in dialysate removal of phosphate [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
Change from baseline dialysate removal levels at end of double dialyzer treatment period.
Change in dialysate removal of phosphate [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline dialysate removal levels at end of single dialyzer treatment period.
Change in dialysate removal of phosphate [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
Change from baseline dialysate removal levels at end of double dialyzer treatment period.

Estimated Enrollment:	34
Study Start Date:	January 2013
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Single dialyzer/standard treatment	Procedure: Standard treatment Hemodialysis treatment using a single dialyser. Is usually considered standard hemodialysis treatment
Active Comparator: Two dialyzers in parallel	Procedure: Two dialyzers Hemodialysis treatment using two dialyzers in parallel.

Detailed Description:

Higher levels of serum phosphate are independently associated with an increased risk of death in hemodialysis patients. Therefore, there has been considerable interest in controlling serum phosphate while minimizing oral calcium load. While most attention has focused on the use of non-calcium containing phosphate binders such as sevelamer and lanthanum, modifying conventional dialysis regimens to improve phosphate clearance is an alternative approach that remains relatively unstudied. A secondary analysis of a previous randomized cross-over study from our group found that the use of two dialysers in parallel resulted in a reduction in pre-dialysis serum phosphate levels. As this study was small, and the mechanisms resulting in the reduction in phosphate levels were unclear, further study is warranted. The investigators will conduct a randomized cross-over study comparing the impact of dialyzing using two dialysers in parallel with a single dialyser in hyperphosphatemic hemodialysis patients.

There will be a total of 34 participants from Alberta,Canada participating in this study. The length of study participation is 8 to 10 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 > 1.8 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.)

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539252

Contacts

Contact: Susan Szigety

780 407-7868

sszigety@ualberta.ca

Locations

Canada, Alberta
University of Calgary	Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Braden Manns, MD 403 944-2595 braden.manns@albertahealthservices.ca
University of Alberta	Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Marcello Tonelli, MD 780 407-8520 mtonelli@ualberta.ca
Contact: Dawn Opgenorth, RN 780 407-1543 dawno@ualberta.ca
Sub-Investigator: Stephanie Thompson, MD

Sponsors and Collaborators

University of Alberta

University of Calgary

Investigators

Principal Investigator:	Marcello Tonelli, MD	University of Alberta
Principal Investigator:	Braden Manns, MD	University of Calgary

More Information

No publications provided

Responsible Party:	Marcello Tonelli, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier:	NCT01539252 History of Changes
Other Study ID Numbers:	DDphos1
Study First Received:	February 3, 2012
Last Updated:	April 4, 2013
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Alberta:

hemodialysis
adequacy
phosphate clearance
double dialyzer
two dialyzers in parallel

Additional relevant MeSH terms:

Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 16, 2013