Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 5
- 主要终点
- Serum phosphate concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Calcium carbonate ( Intensive phosphate control) (Drug)
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.
干预措施: Calcium carbonate (Liberalized phosphate control) (Drug)
结局指标
主要结局
Serum phosphate concentration
时间窗: 26 weeks
次要结局
- 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)
研究者
Ron Wald
Staff Physician, Division of Nephrology; Scientist, Li Ka Shing Knowledge Institute of St. Michael's Hospital
Unity Health Toronto