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

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ClinicalTrials.gov Identifier: NCT01994733
Recruitment Status : Completed
First Posted : November 26, 2013
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ron Wald, Unity Health Toronto

Tracking Information
First Submitted Date  ICMJE November 20, 2013
First Posted Date  ICMJE November 26, 2013
Last Update Posted Date June 23, 2015
Study Start Date  ICMJE January 2014
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
Serum phosphate concentration [ Time Frame: 26 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2013)
  • 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 ]
  • Treatment compliance as defined by taking the study medication at least 80% of the time [ Time Frame: 26 weeks ]
  • Number of serious adverse events [ Time Frame: 26 weeks ]
  • Number of hospitalizations for vascular reasons that are unrelated to dialysis access [ Time Frame: 26 weeks ]
  • Proportion of patients with a vascular death or non-fatal vascular event [ Time Frame: 26 weeks ]
  • Proportion of patients developing serum calcium > 2.60 mmol/L [ Time Frame: 26 weeks ]
  • Number of fractures [ Time Frame: 26 weeks ]
  • Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis) [ Time Frame: 26 weeks ]
  • Change in quality-of-life [ Time Frame: 26 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)
Official Title  ICMJE Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE End-stage Renal Disease
Intervention  ICMJE
  • Drug: Calcium carbonate ( Intensive phosphate control)
    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
    Other Name: Calcium carbonate
  • Drug: Calcium carbonate (Liberalized phosphate control)
    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.
Study Arms  ICMJE
  • Experimental: Intensive phosphate control
    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: Drug: Calcium carbonate ( Intensive phosphate control)
  • Active Comparator: Liberalized phosphate control
    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: Drug: Calcium carbonate (Liberalized phosphate control)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2015)
104
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2013)
100
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01994733
Other Study ID Numbers  ICMJE 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ron Wald, Unity Health Toronto
Study Sponsor  ICMJE Unity Health Toronto
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Ron Wald, MDCM Unity Health Toronto
PRS Account Unity Health Toronto
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP