3600 Participants Needed

Phosphate Level Management for Kidney Failure

(PHOSPHATE Trial)

Recruiting at 104 trial locations
RW
RS
Overseen ByRona Smith
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Queensland
Must be taking: Phosphate-lowering
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on at least one phosphate-lowering medication to participate.

What data supports the effectiveness of phosphate-lowering medications for managing phosphate levels in kidney failure?

Research shows that non-calcium-based phosphate binders can effectively control high phosphate levels in kidney disease patients, reducing the risk of heart-related issues and death compared to calcium-based binders.12345

Are phosphate binders safe for managing phosphate levels in kidney failure?

Phosphate binders are generally considered safe for managing phosphate levels in kidney failure, but they can have side effects, especially affecting the stomach and intestines. Some types, like calcium-based binders, may lead to high calcium levels and other complications, while others like sevelamer and lanthanum carbonate have fewer side effects but can be expensive.16789

How does the Intensive and Liberal phosphate target treatment for kidney failure differ from other treatments?

This treatment is unique because it involves setting specific phosphate level targets (intensive or liberal) to manage kidney failure, using phosphate binders that do not contain calcium, which reduces the risk of vascular calcification and mortality compared to traditional calcium-based binders.125710

What is the purpose of this trial?

During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.

Research Team

Ron Wald

Ron Wald

Principal Investigator

St Michael's Hospital

SG

Suetonia Green

Principal Investigator

University of Otago

PM

Patrick Mark

Principal Investigator

University of Glasgow

RK

Rathika Krishnasamy

Principal Investigator

The University of Queensland

MW

Michael Walsh

Principal Investigator

Hamilton Centre for Kidney Research

RS

Rona Smith

Principal Investigator

University of Cambridge

SB

Sunil Badve

Principal Investigator

The University of Queensland

Eligibility Criteria

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.

Inclusion Criteria

I have been on dialysis for kidney failure for at least 3 months.
I am currently taking medication to lower my phosphate levels.
Able to provide informed consent
See 1 more

Exclusion Criteria

You have a serious illness that could cause death within the next 6 months, according to your doctor.
You are involved in a study that may change the level of phosphate in your blood.
I am scheduled for a kidney transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either intensive or liberal serum phosphate targets and receive phosphate binders as per the assigned target

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on cardiovascular events and quality of life

5 years

Treatment Details

Interventions

  • Intensive phosphate target
  • Liberal phosphate target
Trial Overview 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.
Participant Groups
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.

Intensive phosphate target is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Phosphate binders for:
  • Chronic kidney disease
  • End-stage kidney disease
  • Hyperphosphatemia
🇺🇸
Approved in United States as Phosphate binders for:
  • Chronic kidney disease
  • End-stage kidney disease
  • Hyperphosphatemia
🇨🇦
Approved in Canada as Phosphate binders for:
  • Chronic kidney disease
  • End-stage kidney disease
  • Hyperphosphatemia

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Queensland

Lead Sponsor

Trials
149
Recruited
71,700+

National Health and Medical Research Council, Australia

Collaborator

Trials
167
Recruited
473,000+

Applied Health Research Centre

Collaborator

Trials
23
Recruited
70,900+

Cambridge University Hospitals NHS Foundation Trust

Collaborator

Trials
280
Recruited
501,000+

University of Otago

Collaborator

Trials
40
Recruited
60,100+

Findings from Research

Phosphate binders are commonly prescribed for patients with chronic kidney disease (CKD) and kidney failure, but there is no clear evidence that one class of binder is superior to another in improving clinical outcomes, despite their widespread use.
The use of phosphate binders can significantly increase the number of pills patients must take and their out-of-pocket costs, raising concerns about their overall benefit and the best options for managing phosphate levels in CKD.
State-of-the-Art Management of Hyperphosphatemia in Patients With CKD: An NKF-KDOQI Controversies Perspective.Scialla, JJ., Kendrick, J., Uribarri, J., et al.[2023]
Non-calcium-based phosphate binders (NCBB) are associated with a 22% reduction in all-cause mortality compared to calcium-based phosphate binders (CBB), making them a safer option for managing hyperphosphatemia in chronic kidney disease (CKD).
The timing of initiating phosphate binder treatment in CKD patients remains uncertain, as recent studies indicate that active treatment may lead to increased vascular calcification progression without effectively balancing phosphate levels.
Advances in pharmacotherapy for hyperphosphatemia in renal disease.Spasovski, G.[2018]
Hyperphosphatemia, or high phosphate levels, is linked to increased cardiovascular risks and mortality in patients with chronic kidney disease (CKD), but there are no randomized controlled trials proving that lowering phosphate levels improves hard outcomes in these patients.
Traditional calcium-based phosphate binders may pose a risk of vascular mineralization, prompting the need for new phosphate-lowering therapies and individualized treatment approaches based on patient risk factors.
Phosphate Binders and Targets Over Decades: Do We have it Right Now?Marcuccilli, M., Chonchol, M., Jovanovich, A.[2018]

References

State-of-the-Art Management of Hyperphosphatemia in Patients With CKD: An NKF-KDOQI Controversies Perspective. [2023]
Advances in pharmacotherapy for hyperphosphatemia in renal disease. [2018]
Phosphate Binders and Targets Over Decades: Do We have it Right Now? [2018]
Phosphate binders: new products and challenges. [2018]
A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis. [2020]
Oral phosphate binders. [2016]
Oral phosphate binders in CKD - is calcium the (only) answer? [2022]
Past, Present, and Future of Phosphate Management. [2022]
[New Developments in CKD-MBD. New aspects in phosphate binders]. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
A comparison of clinically useful phosphorus binders for patients with chronic kidney failure. [2019]
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