Evaluating phosphate level targets in patients with end-stage kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the impact of lowering blood phosphate levels in patients with end-stage kidney disease (ESKD) on critical health outcomes. It compares a liberal phosphate target of 2.0 to 2.5 mmol/L with an intensive target of ≤1.50 mmol/L to determine which approach better reduces the risk of cardiovascular events and improves overall patient health. The study involves 3600 adult patients receiving dialysis and utilizes phosphate binders as part of the treatment regimen. The primary focus is on patient-centered outcomes, including mortality and quality of life.

Why it matters

Who can join: the full rules

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.

Where it's running

• Serviço Ubaense de Nefrologia Ltda
  Ubá, Minas Gerais, Brazil Recruiting
• BRA Santa Casa de Misericórdia de Ponta Grossa
  Ponta Grossa, Paraná, Brazil Recruiting
• Sociedade Hospitalar Angelina Caron
  Campina Grande, Paraíba, Brazil Recruiting
• Hospital de Clinicas Porto Alegre
  Porto Alegre, Rio Grande do Sul, Brazil Recruiting
• Fundacao Felice Rosso - Hospital Felicio Rocho
  Barro Preto, Brazil Recruiting
• Hospital Alemao Oswaldo Cruz
  São Paulo, Brazil Recruiting

+76 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Sunil Badve — University of New South Wales
• Study coordinator: Ron Wald
• Email: WaldR@smh.ca
• Phone: 416 867 3703

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.