Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)

End-stage Renal Disease Clinical Trial

— TARGET  

Official title:

Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994733
• Other study ID #: 001
• Status: Completed
• Phase: Phase 2
• First received: November 20, 2013
• Last updated: June 22, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Calcium 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
• Calcium 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

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