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Phosphate Binder

Phosphate Level Management for Kidney Failure (PHOSPHATE Trial)

N/A

Recruiting

Led By Suetonia Palmer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PHOSPHATE Trial 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.Check my eligibility

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.See study design

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.

PHOSPHATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am currently taking medication to lower my phosphate levels.

Select...

I am 45 or older, or I am 18 or older with diabetes.

PHOSPHATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to a composite endpoint of cardiovascular death or non-fatal major cardiovascular event

Secondary outcome measures

Time to all-cause death

Time to individual components of the primary composite endpoint

Utility-based quality of life EQ5D-5L

Other outcome measures

Cost-effectiveness analysis

Differences in the serum concentrations of phosphate, PTH, calcium, alkaline phosphatase and albumin

Gastrointestinal Symptom Rating Scale

+5 more

PHOSPHATE 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of QueenslandLead Sponsor

140 Previous Clinical Trials

62,616 Total Patients Enrolled

National Health and Medical Research Council, AustraliaOTHER

165 Previous Clinical Trials

471,537 Total Patients Enrolled

Applied Health Research CentreOTHER

22 Previous Clinical Trials

67,436 Total Patients Enrolled

Media Library

Intensive phosphate target (Phosphate Binder) Clinical Trial Eligibility Overview. Trial Name: NCT03573089 — N/A

Chronic Kidney Failure Research Study Groups: Liberal phosphate target, Intensive phosphate target

Chronic Kidney Failure 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are eligible for enrollment in this clinical trial?

"This scientific study necessitates 3,600 participants who meet the established inclusion criteria. Eligible patients can join this trial at Jewish General Hospital in Montréal or Hopital Maisonneuve Rosemont in Montreal."

Answered by AI

Are there any opportunities for subjects to participate in this research at the moment?

"According to clinicaltrials.gov, this medicinal trial is actively enrolling participants since its initial posting on December 10th 2019 and last edit on September 15th 2022."

Answered by AI

Are there a considerable number of sites in North America operating this clinical experiment?

"This experiment is being conducted at 20 different sites, including Montreal and Halifax. To keep travel to a minimum, it's best for participants to select the nearest location during their enrollment process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

2019. "Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03573089.

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