Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients
Overview
- Phase
- Phase 2
- Intervention
- Calcium carbonate ( Intensive phosphate control)
- Conditions
- End-stage Renal Disease
- Sponsor
- Unity Health Toronto
- Enrollment
- 104
- Locations
- 5
- Primary Endpoint
- Serum phosphate concentration
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Ron Wald
Staff Physician, Division of Nephrology; Scientist, Li Ka Shing Knowledge Institute of St. Michael's Hospital
Unity Health Toronto
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
- •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
Arms & Interventions
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: Calcium carbonate ( Intensive phosphate control)
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: Calcium carbonate (Liberalized phosphate control)
Outcomes
Primary Outcomes
Serum phosphate concentration
Time Frame: 26 weeks
Secondary Outcomes
- 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)