Clinical trial NCT01994733: Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)
Official title: Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End-stage Renal Disease
Keywords: end-stage renal disease
hemodialysis
mineral metabolism
serum phosphate
phosphate binders
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-11-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum phosphate concentration
timeFrame: 26 weeks
Secondary outcomes:
measure: Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized
timeFrame: 26 weeks
measure: Treatment compliance as defined by taking the study medication at least 80% of the time
timeFrame: 26 weeks
measure: Number of serious adverse events
timeFrame: 26 weeks
measure: Number of hospitalizations for vascular reasons that are unrelated to dialysis access
timeFrame: 26 weeks
measure: Proportion of patients with a vascular death or non-fatal vascular event
timeFrame: 26 weeks
measure: Proportion of patients developing serum calcium > 2.60 mmol/L
timeFrame: 26 weeks
measure: Number of fractures
timeFrame: 26 weeks
measure: Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis)
timeFrame: 26 weeks
measure: Change in quality-of-life
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Halifax
country: Canada
facility: Capital District Health Authority
state: Nova Scotia
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Ron Wald, MDCM
role: PRINCIPAL_INVESTIGATOR
References: