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NCT Number: NCT01994733

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

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.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium carbonate ( Intensive phosphate control)

Drug

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 names: Calcium carbonate

Calcium carbonate (Liberalized phosphate control)

Drug

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 outcomes

  1. Serum phosphate concentration

    Time frame: 26 weeks

Secondary outcomes

  1. 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

  2. Treatment compliance as defined by taking the study medication at least 80% of the time

    Time frame: 26 weeks

  3. Number of serious adverse events

    Time frame: 26 weeks

  4. Number of hospitalizations for vascular reasons that are unrelated to dialysis access

    Time frame: 26 weeks

  5. Proportion of patients with a vascular death or non-fatal vascular event

    Time frame: 26 weeks

  6. Proportion of patients developing serum calcium > 2.60 mmol/L

    Time frame: 26 weeks

  7. Number of fractures

    Time frame: 26 weeks

  8. Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis)

    Time frame: 26 weeks

  9. Change in quality-of-life

    Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients

Acronym: TARGET

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 26, 2013
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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