Study Summary
This trial will test whether reducing blood phosphate levels for people with end-stage kidney disease will improve health outcomes and be cost-effective.
Eligible Conditions
- Chronic Kidney Failure
- High Phosphate Levels
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 5 years
5 years
Cost-effectiveness analysis
Gastrointestinal Symptom Rating Scale
Itch/pruritus visual analog scale
Phosphate-lowering medication self-reported adherence
Phosphate-lowering medication usage
Proportion of patients developing calciphylaxis
Proportion of patients requiring parathyroidectomy
Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event
Time to all-cause death
Time to individual components of the primary composite endpoint
Utility-based quality of life EQ5D-5L
Time Frame: 5 years
Differences in the serum concentrations of phosphate, PTH, calcium, alkaline phosphatase and albumin
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Liberal phosphate target
1 of 2
Intensive phosphate target
1 of 2
Active Control
Experimental Treatment
3600 Total Participants · 2 Treatment Groups
Primary Treatment: Intensive phosphate target · No Placebo Group · N/A
Intensive phosphate target
Drug
Experimental Group · 1 Intervention: Intensive phosphate target · Intervention Types: DrugLiberal phosphate target
Drug
ActiveComparator Group · 1 Intervention: Liberal phosphate target · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
Who is running the clinical trial?
National Health and Medical Research Council, AustraliaOTHER
161 Previous Clinical Trials
467,418 Total Patients Enrolled
University of OtagoOTHER
34 Previous Clinical Trials
35,570 Total Patients Enrolled
Cambridge University Hospitals NHS Foundation TrustOTHER
252 Previous Clinical Trials
468,436 Total Patients Enrolled
The University of QueenslandLead Sponsor
128 Previous Clinical Trials
58,844 Total Patients Enrolled
Applied Health Research CentreOTHER
21 Previous Clinical Trials
68,033 Total Patients Enrolled
Patrick MarkPrincipal InvestigatorUniversity of Glasgow
Ron WaldPrincipal InvestigatorUnity Health Toronto
2 Previous Clinical Trials
309 Total Patients Enrolled
Sunil BadvePrincipal InvestigatorThe University of Queensland
1 Previous Clinical Trials
2,000 Total Patients Enrolled
Rona SmithPrincipal InvestigatorUniversity of Cambridge
Rathika KrishnasamyPrincipal InvestigatorThe University of Queensland
Suetonia PalmerPrincipal InvestigatorUniversity of Otago
Michael WalshPrincipal InvestigatorHamilton Centre for Kidney Research
1 Previous Clinical Trials
158 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:People who are at least 45 years old, or at least 18 years old and have diabetes, are at a higher risk for heart disease.
ESKD patients require dialysis treatments three times a week
People who have ESKD require dialysis treatments three times a week in order to remove toxins from their blood
At least one person taking a medication to lower their phosphate levels.
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Conditions
Cancer Related
Treatments