End-stage Renal Disease Clinical Trial
— TARGETOfficial title:
Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients
Verified date | June 2015 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Foothills Medical Centre | Calgary | Alberta |
Canada | Capital District Health Authority | Halifax | Nova Scotia |
Canada | St. Joseph's Healthcare | Hamilton | Ontario |
Canada | London Health Sciences Centre | London | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum phosphate concentration | 26 weeks | No | |
Secondary | Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized | 26 weeks | No | |
Secondary | Treatment compliance as defined by taking the study medication at least 80% of the time | 26 weeks | No | |
Secondary | Number of serious adverse events | 26 weeks | Yes | |
Secondary | Number of hospitalizations for vascular reasons that are unrelated to dialysis access | 26 weeks | Yes | |
Secondary | Proportion of patients with a vascular death or non-fatal vascular event | 26 weeks | No | |
Secondary | Proportion of patients developing serum calcium > 2.60 mmol/L | 26 weeks | Yes | |
Secondary | Number of fractures | 26 weeks | Yes | |
Secondary | Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis) | 26 weeks | Yes | |
Secondary | Change in quality-of-life | 26 weeks | No |
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