End-stage Renal DiseasePhase 2TARGETNCT01994733
Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET)
A Phase 2 study of End-stage Renal Disease, run by Unity Health Toronto at 5 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-stage Renal Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 5 sitesCanada
- Study dates
- Jan 2014to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Capital District Health Authority
Halifax, Nova Scotia, B3H 1V7
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
London Health Sciences Centre
London, Ontario, N6G 2V4
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients
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.
- Conditions
- End-stage Renal Disease
- Being tested
- Calcium carbonate ( Intensive phosphate control), Calcium carbonate (Liberalized phosphate control)
- Keywords
- end-stage renal disease, hemodialysis, mineral metabolism, serum phosphate, phosphate binders
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium carbonate ( Intensive phosphate control)Drug
Also called Calcium carbonate
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)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Calcium carbonate ( Intensive phosphate control) |
| 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. Receives: Drug: Calcium carbonate (Liberalized phosphate control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum phosphate concentration
Measured: 26 weeks
Secondary outcomes (9)
Number of patients who successfully achieved target serum P at week 26 based on the arm to which they were randomized
Measured: 26 weeks
Treatment compliance as defined by taking the study medication at least 80% of the time
Measured: 26 weeks
Number of serious adverse events
Measured: 26 weeks
Number of hospitalizations for vascular reasons that are unrelated to dialysis access
Measured: 26 weeks
Proportion of patients with a vascular death or non-fatal vascular event
Measured: 26 weeks
Proportion of patients developing serum calcium > 2.60 mmol/L
Measured: 26 weeks
Number of fractures
Measured: 26 weeks
Number of patients developing calcific uremic arteriolopathy (ie, calciphylaxis)
Measured: 26 weeks
Change in quality-of-life
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Ron Wald, Unity Health Toronto
- Investigators
- Ron Wald, MDCM, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994733
- Sponsor's protocol ID
- 001
- Acronym
- TARGET
- Status last verified
- Jun 2015
- First submitted
- 20 Nov 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two phosphAte taRGets in End-stage Renal Disease Trial (TARGET): Intensive vs Liberalized Phosphate Control in Hemodialysis Recipients
- ClinicalTrials.gov ID
- NCT01994733
- Acronym / sponsor ID
- TARGET / 001
- Conditions
- End-stage Renal Disease
- Keywords
- end-stage renal disease, hemodialysis, mineral metabolism, serum phosphate, phosphate binders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive phosphate control | Experimental | 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. |
| Liberalized phosphate control | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium carbonate ( Intensive phosphate control)Also: Calcium carbonateIndividuals 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 | Intensive phosphate control |
| 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. | Drug | Liberalized phosphate control |
Primary outcome
Serum phosphate concentration
Time frame: 26 weeks
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Wald, MDCM principal investigator
Unity Health Toronto
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of End-stage Renal Disease, run by Unity Health Toronto at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum phosphate concentration (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.