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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01994733
Other study ID # 001
Secondary ID
Status Completed
Phase Phase 2
First received November 20, 2013
Last updated June 22, 2015
Start date January 2014
Est. completion date April 2015

Study information

Verified date June 2015
Source St. Michael's Hospital, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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
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.

Locations

Country Name City State
Canada Foothills Medical Centre Calgary Alberta
Canada Capital District Health Authority Halifax Nova Scotia
Canada St. Joseph's Healthcare Hamilton Ontario
Canada London Health Sciences Centre London Ontario
Canada St. Michael's Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum phosphate concentration 26 weeks No
Secondary Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized 26 weeks No
Secondary Treatment compliance as defined by taking the study medication at least 80% of the time 26 weeks No
Secondary Number of serious adverse events 26 weeks Yes
Secondary Number of hospitalizations for vascular reasons that are unrelated to dialysis access 26 weeks Yes
Secondary Proportion of patients with a vascular death or non-fatal vascular event 26 weeks No
Secondary Proportion of patients developing serum calcium > 2.60 mmol/L 26 weeks Yes
Secondary Number of fractures 26 weeks Yes
Secondary Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis) 26 weeks Yes
Secondary Change in quality-of-life 26 weeks No
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