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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive phosphate control | Experimental | 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. |
|
| Liberalized phosphate control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium carbonate ( Intensive phosphate control) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum phosphate concentration | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized | 26 weeks | |
| Treatment compliance as defined by taking the study medication at least 80% of the time | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ron Wald, MDCM | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| Capital District Health Authority |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
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|
| Calcium carbonate (Liberalized phosphate control) | Drug | 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. |
|
| Number of serious adverse events | 26 weeks |
| Number of hospitalizations for vascular reasons that are unrelated to dialysis access | 26 weeks |
| Proportion of patients with a vascular death or non-fatal vascular event | 26 weeks |
| Proportion of patients developing serum calcium > 2.60 mmol/L | 26 weeks |
| Number of fractures | 26 weeks |
| Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis) | 26 weeks |
| Change in quality-of-life | 26 weeks |
| Halifax |
| Nova Scotia |
| B3H 1V7 |
| Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | L8N 4A6 | Canada |
| London Health Sciences Centre | London | Ontario | N6G 2V4 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |