Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)
- Conditions
- End-stage Renal Disease
- Interventions
- Registration Number
- NCT01994733
- Lead Sponsor
- Unity Health Toronto
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive phosphate control 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. Liberalized phosphate control 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.
- Primary Outcome Measures
Name Time Method Serum phosphate concentration 26 weeks
- Secondary Outcome Measures
Name Time Method Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized 26 weeks Treatment compliance as defined by taking the study medication at least 80% of the time 26 weeks Number of serious adverse events 26 weeks Number of hospitalizations for vascular reasons that are unrelated to dialysis access 26 weeks Proportion of patients with a vascular death or non-fatal vascular event 26 weeks Proportion of patients developing serum calcium > 2.60 mmol/L 26 weeks Number of fractures 26 weeks Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis) 26 weeks Change in quality-of-life 26 weeks
Trial Locations
- Locations (5)
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
St. Joseph's Healthcare
🇨🇦Hamilton, Ontario, Canada
Capital District Health Authority
🇨🇦Halifax, Nova Scotia, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada