A Phase 2 interventional study of Calcium carbonate ( Intensive phosphate control) and Calcium carbonate (Liberalized phosphate control) in End-stage Renal Disease, sponsored by Unity Health Toronto. Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-23.
Sponsored by Unity Health Toronto · Phase 2, Interventional, and Treatment
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.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's enrollment of 104 is above the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Unity Health Toronto is the lead sponsor of 444 studies on the registry; 80 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
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 ( Intensive 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.
Drug: Calcium carbonate (Liberalized 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
Also known as: Calcium carbonate
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.
Serum phosphate concentration
Time frame: 26 weeks
Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized
Time frame: 26 weeks
Treatment compliance as defined by taking the study medication at least 80% of the time
Time frame: 26 weeks
Number of serious adverse events
Time frame: 26 weeks
Number of hospitalizations for vascular reasons that are unrelated to dialysis access
Time frame: 26 weeks
Proportion of patients with a vascular death or non-fatal vascular event
Time frame: 26 weeks
Proportion of patients developing serum calcium > 2.60 mmol/L
Time frame: 26 weeks
Number of fractures
Time frame: 26 weeks
Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis)
Time frame: 26 weeks
Change in quality-of-life
Time frame: 26 weeks
The record gives a start of Jan 2014, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Calcium Carbonate