End-stage Renal Disease
Conditions
Keywords
end-stage renal disease, hemodialysis, mineral metabolism, serum phosphate, phosphate binders
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.
Interventions
DRUGCalcium 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
DRUGCalcium 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.
Sponsors
Canadian Institutes of Health Research (CIHR)
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum phosphate concentration | 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis) | 26 weeks |
| 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 hospitalizations for vascular reasons that are unrelated to dialysis access | 26 weeks |
| Number of serious adverse events | 26 weeks |
| Proportion of patients developing serum calcium > 2.60 mmol/L | 26 weeks |
| Number of fractures | 26 weeks |
| Change in quality-of-life | 26 weeks |
| Proportion of patients with a vascular death or non-fatal vascular event | 26 weeks |
Countries
Canada
Outcome results
None listed