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Phosphate Binder

Phosphate Level Management for Kidney Failure (PHOSPHATE Trial)

N/A
Recruiting
Led By Suetonia Green
Research Sponsored by The University of Queensland
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently prescribed at least one phosphate-lowering medication at any dose
Age ≥45 years, or Age ≥18 years with diabetes
Must not have
Elective kidney transplantation scheduled
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for adults with end-stage kidney disease (ESKD) who have been on dialysis for at least 3 months and are taking medication to lower phosphate levels. It's open to those over 45, or over 18 with diabetes, who can consent. People expecting a kidney transplant soon, in other trials affecting phosphate levels, or with illnesses likely causing death within six months cannot join.
What is being tested?
The PHOSPHATE trial is testing whether it's better for patients' health and more cost-effective to aim for high or intensive targets in lowering blood phosphate levels among those with chronic kidney failure. The impact on survival rates, heart events, and physical well-being will be compared.
What are the potential side effects?
While the trial itself may not directly cause side effects, managing phosphate levels could lead to imbalances that affect bone health and muscle function. Phosphate-lowering medications might also cause digestive issues like nausea or diarrhea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently taking medication to lower my phosphate levels.
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I am 45 or older, or I am 18 or older with diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for a kidney transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event
Secondary study objectives
Utility-based quality of life EQ5D-5L
Other study objectives
Cost-effectiveness analysis
Gastrointestinal Symptom Rating Scale
Itch/pruritus visual analog scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive phosphate targetExperimental Treatment1 Intervention
Intensive serum phosphate target of ≤1.50 mmol/L.
Group II: Liberal phosphate targetActive Control1 Intervention
Liberal serum phosphate target of 2.0 to 2.5 mmol/L.

Find a Location

Who is running the clinical trial?

The University of QueenslandLead Sponsor
145 Previous Clinical Trials
66,684 Total Patients Enrolled
National Health and Medical Research Council, AustraliaOTHER
166 Previous Clinical Trials
473,106 Total Patients Enrolled
Applied Health Research CentreOTHER
22 Previous Clinical Trials
67,296 Total Patients Enrolled
Cambridge University Hospitals NHS Foundation TrustOTHER
276 Previous Clinical Trials
496,308 Total Patients Enrolled
University of OtagoOTHER
38 Previous Clinical Trials
56,389 Total Patients Enrolled
Suetonia GreenPrincipal InvestigatorUniversity of Otago
Suetonia PalmerPrincipal InvestigatorUniversity of Otago
Patrick MarkPrincipal InvestigatorUniversity of Glasgow
Rathika KrishnasamyPrincipal InvestigatorThe University of Queensland
Michael WalshPrincipal InvestigatorHamilton Centre for Kidney Research
1 Previous Clinical Trials
158 Total Patients Enrolled

Media Library

Intensive phosphate target (Phosphate Binder) Clinical Trial Eligibility Overview. Trial Name: NCT03573089 — N/A
Hyperphosphatemia Research Study Groups: Liberal phosphate target, Intensive phosphate target
Hyperphosphatemia Clinical Trial 2023: Intensive phosphate target Highlights & Side Effects. Trial Name: NCT03573089 — N/A
Intensive phosphate target (Phosphate Binder) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03573089 — N/A
~1350 spots leftby Dec 2027
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