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Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET) (TARGET)

Primary Purpose

End-stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Calcium carbonate ( Intensive phosphate control)
Calcium carbonate (Liberalized phosphate control)
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease focused on measuring end-stage renal disease, hemodialysis, mineral metabolism, serum phosphate, phosphate binders

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 18 yrs
  2. Receiving chronic hemodialysis for > 90 days,
  3. Dialysis prescription is currently no more than 4 sessions per week and prescribed as 3-5 hrs per session
  4. Most recent P value 1.30-2.50 mmol/L
  5. Receipt of a calcium-based P binder

Exclusion Criteria:

  1. Patient is booked (with a known surgical date) for a live donor kidney transplant in the next 26 weeks
  2. Planned switch to a dialysis schedule that involves > 16 hours per week of therapy within the next 26 weeks.
  3. Planned switch to peritoneal dialysis within the next 26 weeks
  4. Pregnancy
  5. Albumin-corrected serum calcium > 2.60 mmol/L in the past year requiring reduction of the calcium carbonate dose
  6. History of calciphylaxis
  7. Attending nephrologist believes that an otherwise eligible patient is mandated- on clinical grounds- to have a P value that is targeted to < 1.50 mmol/L or > 2.00 mmol/L
  8. Attending nephrologist believes an otherwise eligible patient is not a candidate for escalation of the current calcium dose
  9. Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein

Sites / Locations

  • Foothills Medical Centre
  • Capital District Health Authority
  • St. Joseph's Healthcare
  • London Health Sciences Centre
  • St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive phosphate control

Liberalized phosphate control

Arm Description

Individuals randomized to this arm will be exposed to a treatment strategy that targets a P of < 1.50 mmol/L, reflecting the recommendations of current guidelines. Titration of the calcium carbonate dose will be the core of this approach and this will be complemented by usual recommendations regarding dietary P restriction. Dietitians will be available to provide counseling with regards to any aspect of the end-stage renal disease diet, as per usual dialysis unit practice.

Individuals in this arm will be exposed to a treatment strategy that allows P to rise above 2.00 mmol/L. This will be accomplished through structured reduction of P binders already in use (as per the algorithm detailed below). "Rescue" P binding will be instituted if P rises above 2.50 mmol/L. Dietitians will be available to provide counseling regarding any aspect of the end-stage renal disease diet, as per usual dialysis unit practice, but will not provide counseling on dietary P restriction unless the P rises above 2.50 mmol/L.

Outcomes

Primary Outcome Measures

Serum phosphate concentration

Secondary Outcome Measures

Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized
Treatment compliance as defined by taking the study medication at least 80% of the time
Number of serious adverse events
Number of hospitalizations for vascular reasons that are unrelated to dialysis access
Proportion of patients with a vascular death or non-fatal vascular event
Proportion of patients developing serum calcium > 2.60 mmol/L
Number of fractures
Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis)
Change in quality-of-life

Full Information

First Posted
November 20, 2013
Last Updated
June 22, 2015
Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01994733
Brief Title
Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)
Acronym
TARGET
Official Title
Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with end-stage renal disease (ESRD) who have elevated serum phosphate (P) levels have significantly higher mortality rates compared to those with normal P. In patients receiving conventional dialysis regimens, serum P may be lowered through dietary intervention and use of P binders, though these have potentially important side effects and may adversely impact quality of life. Whether lowering P, and / or targeting specific P levels improve survival and clinical outcomes is unknown. Despite this uncertainty, over 90% of patients with ESRD receive P lowering therapy and guidelines for the care of patients with ESRD are increasingly calling for more aggressive phosphate lowering. This intensive P lowering results in extra medications (and their associated side-effects), and higher health care costs. We are uncertain whether the intensification of P control results in measurable benefits to patients with ESRD. The overall goal of this pilot trial is to evaluate the feasibility of conducting a randomized controlled trial of intensive vs liberalized phosphate control among hemodialysis recipients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease
Keywords
end-stage renal disease, hemodialysis, mineral metabolism, serum phosphate, phosphate binders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive phosphate control
Arm Type
Experimental
Arm Description
Individuals randomized to this arm will be exposed to a treatment strategy that targets a P of < 1.50 mmol/L, reflecting the recommendations of current guidelines. Titration of the calcium carbonate dose will be the core of this approach and this will be complemented by usual recommendations regarding dietary P restriction. Dietitians will be available to provide counseling with regards to any aspect of the end-stage renal disease diet, as per usual dialysis unit practice.
Arm Title
Liberalized phosphate control
Arm Type
Active Comparator
Arm Description
Individuals in this arm will be exposed to a treatment strategy that allows P to rise above 2.00 mmol/L. This will be accomplished through structured reduction of P binders already in use (as per the algorithm detailed below). "Rescue" P binding will be instituted if P rises above 2.50 mmol/L. Dietitians will be available to provide counseling regarding any aspect of the end-stage renal disease diet, as per usual dialysis unit practice, but will not provide counseling on dietary P restriction unless the P rises above 2.50 mmol/L.
Intervention Type
Drug
Intervention Name(s)
Calcium carbonate ( Intensive phosphate control)
Other Intervention Name(s)
Calcium carbonate
Intervention Description
Individuals randomized to this arm will be exposed to a treatment strategy that targets a P of < 1.50 mmol/L, reflecting the recommendations of current guidelines. Titration of the calcium carbonate dose will be the core of this approach and this will be complemented by usual recommendations regarding dietary P restriction. Dietitians will be available to provide counseling with regards to any aspect of the end-stage renal disease diet, as per usual dialysis unit practice
Intervention Type
Drug
Intervention Name(s)
Calcium carbonate (Liberalized phosphate control)
Intervention Description
Individuals in this arm will be exposed to a treatment strategy that allows P to rise above 2.00 mmol/L. This will be accomplished through structured reduction of P binders already in use (as per the algorithm detailed below). "Rescue" P binding will be instituted if P rises above 2.50 mmol/L. Dietitians will be available to provide counseling regarding any aspect of the end-stage renal disease diet, as per usual dialysis unit practice, but will not provide counseling on dietary P restriction unless the P rises above 2.50 mmol/L.
Primary Outcome Measure Information:
Title
Serum phosphate concentration
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized
Time Frame
26 weeks
Title
Treatment compliance as defined by taking the study medication at least 80% of the time
Time Frame
26 weeks
Title
Number of serious adverse events
Time Frame
26 weeks
Title
Number of hospitalizations for vascular reasons that are unrelated to dialysis access
Time Frame
26 weeks
Title
Proportion of patients with a vascular death or non-fatal vascular event
Time Frame
26 weeks
Title
Proportion of patients developing serum calcium > 2.60 mmol/L
Time Frame
26 weeks
Title
Number of fractures
Time Frame
26 weeks
Title
Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis)
Time Frame
26 weeks
Title
Change in quality-of-life
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 yrs Receiving chronic hemodialysis for > 90 days, Dialysis prescription is currently no more than 4 sessions per week and prescribed as 3-5 hrs per session Most recent P value 1.30-2.50 mmol/L Receipt of a calcium-based P binder Exclusion Criteria: Patient is booked (with a known surgical date) for a live donor kidney transplant in the next 26 weeks Planned switch to a dialysis schedule that involves > 16 hours per week of therapy within the next 26 weeks. Planned switch to peritoneal dialysis within the next 26 weeks Pregnancy Albumin-corrected serum calcium > 2.60 mmol/L in the past year requiring reduction of the calcium carbonate dose History of calciphylaxis Attending nephrologist believes that an otherwise eligible patient is mandated- on clinical grounds- to have a P value that is targeted to < 1.50 mmol/L or > 2.00 mmol/L Attending nephrologist believes an otherwise eligible patient is not a candidate for escalation of the current calcium dose Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ron Wald, MDCM
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Capital District Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
St. Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6G 2V4
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

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