Clinical trial

An Investigator-initiated, International, Multi-centre, Prospective, Randomized, Open-label, Parallel-group, Superiority, and Pragmatic Large Simple Trial (LST) to Determine Whether the Currently Recommended Strategy of Intensive Reduction of Serum Phosphate Concentration Towards the Normal Level Results in Significant Patient-centred Benefits in End-stage Kidney Disease (ESKD) Patients Receiving Dialysis.

Name

17.02

Description

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.

Trial arms

Trial start

2019-12-10

Estimated PCD

2027-12-31

Trial end

2028-12-31

Status

Recruiting

Treatment

Liberal phosphate target

All phosphate-lowering medications in use at baseline will be discontinued. Phosphate-lowering medications will be prescribed only if serum phosphate concentration exceeds 2.50 mmol/L. The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.

Arms:

Liberal phosphate target

Intensive phosphate target

This will be achieved by prescribing phosphate-lowering medications aimed to intensively lower serum phosphate concentration towards normal level (≤1.50 mmol/L). The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.

Arms:

Intensive phosphate target

Size

3600

Primary endpoint

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

5 years

Eligibility criteria

Inclusion Criteria: 1. Age ≥45 years, or Age ≥18 years with diabetes, 2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months, 3. Currently prescribed at least one phosphate-lowering medication at any dose 4. Able to provide informed consent Exclusion Criteria: 1. Elective kidney transplantation scheduled, 2. Concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician, 3. Participation in an interventional study that is likely to affect serum phosphate concentration.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 3600, 'type': 'ESTIMATED'}}

Updated at

2024-05-10

1 organization

2 products

3 indications

Organization

The University of Queensland

Product

Liberal phosphate target

Indication

Indication

Indication

Product