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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Ron Wald, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01994733
First received: November 20, 2013
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
End-stage Renal Disease
Drug: Calcium carbonate ( Intensive phosphate control)
Drug: Calcium carbonate (Liberalized phosphate control)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Serum phosphate concentration [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Treatment compliance as defined by taking the study medication at least 80% of the time [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Number of serious adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of hospitalizations for vascular reasons that are unrelated to dialysis access [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of patients with a vascular death or non-fatal vascular event [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients developing serum calcium > 2.60 mmol/L [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of fractures [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis) [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • Change in quality-of-life [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994733

Contacts
Contact: Ron Wald, MDCM 416-867-3703 waldr@smh.ca
Contact: Michael W Walsh, MD lastwalsh1975@gmail.com

Locations
Canada, Alberta
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Louis Girard, MD       lgirard@ucalgary.ca   
Principal Investigator: Louis Girard, MD         
Canada, Ontario
St. Joseph's Healthcare Not yet recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Michael W Walsh, MD       lastwalsh1975@gmail.com   
Contact: Andrea Mazetti    (905) 522-1155 ext 35368    amazzett@stjosham.on.ca   
Principal Investigator: Michael W Walsh, MD         
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6G 2V4
Contact: Amit X Garg, MD       amit.garg@lhsc.on.ca   
Contact: Tanya Wiebe       tanya.wiebe@lhsc.on.ca   
Principal Investigator: Amit X Garg, MD         
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Ron Wald, MD    416-867-3703    waldr@smh.ca   
Contact: Andrea Rathe, MSc       rathea@smh.ca   
Principal Investigator: Ron Wald, MDCM         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Ron Wald, MDCM St. Michael's Hospital, Toronto
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: 001
Study First Received: November 20, 2013
Last Updated: November 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
end-stage renal disease
hemodialysis
mineral metabolism
serum phosphate
phosphate binders

Additional relevant MeSH terms:
Calcium, Dietary
Calcium Carbonate
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014