Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET) (TARGET)
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ClinicalTrials.gov Identifier: NCT01994733 |
Recruitment Status :
Completed
First Posted : November 26, 2013
Last Update Posted : June 23, 2015
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Condition or disease | Intervention/treatment | Phase |
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End-stage Renal Disease | Drug: Calcium carbonate ( Intensive phosphate control) Drug: Calcium carbonate (Liberalized phosphate control) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | April 2015 |
Actual Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
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Experimental: 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.
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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
Other Name: Calcium carbonate |
Active Comparator: 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.
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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. |
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 yrs
- Receiving chronic hemodialysis for > 90 days,
- Dialysis prescription is currently no more than 4 sessions per week and prescribed as 3-5 hrs per session
- Most recent P value 1.30-2.50 mmol/L
- Receipt of a calcium-based P binder
Exclusion Criteria:
- Patient is booked (with a known surgical date) for a live donor kidney transplant in the next 26 weeks
- Planned switch to a dialysis schedule that involves > 16 hours per week of therapy within the next 26 weeks.
- Planned switch to peritoneal dialysis within the next 26 weeks
- Pregnancy
- Albumin-corrected serum calcium > 2.60 mmol/L in the past year requiring reduction of the calcium carbonate dose
- History of calciphylaxis
- 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
- Attending nephrologist believes an otherwise eligible patient is not a candidate for escalation of the current calcium dose
- Co-enrollment in a clinical trial where the intervention is deemed to interfere with the adherence, safety or efficacy of the intervention provided herein

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994733
Canada, Alberta | |
Foothills Medical Centre | |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada, Nova Scotia | |
Capital District Health Authority | |
Halifax, Nova Scotia, Canada, B3H 1V7 | |
Canada, Ontario | |
St. Joseph's Healthcare | |
Hamilton, Ontario, Canada, L8N 4A6 | |
London Health Sciences Centre | |
London, Ontario, Canada, N6G 2V4 | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B 1W8 |
Principal Investigator: | Ron Wald, MDCM | St. Michael's Hospital, Toronto |
Responsible Party: | Ron Wald, Staff Physician, Division of Nephrology; Scientist, Li Ka Shing Knowledge Institute of St. Michael's Hospital, St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT01994733 |
Other Study ID Numbers: |
001 |
First Posted: | November 26, 2013 Key Record Dates |
Last Update Posted: | June 23, 2015 |
Last Verified: | June 2015 |
end-stage renal disease hemodialysis mineral metabolism serum phosphate phosphate binders |
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Calcium, Dietary Calcium Carbonate |
Calcium Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Bone Density Conservation Agents Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |