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

End-stage Renal Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

End-stage Renal Disease

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Drug: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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Intensive phosphate controlIndividuals 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.

Liberalized phosphate controlIndividuals 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.

Study Status

Completed

Start Date: January 2014

Completed Date: April 2015

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Serum phosphate concentration

Secondary Outcome: Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized

Study sponsors, principal investigator, and references

Principal Investigator: Ron Wald, MDCM

Lead Sponsor: St. Michael's Hospital, Toronto

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT01994733

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