AP301, an iron-based phosphate binder, for people on dialysis with high blood phosphate

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

After stopping other phosphate-lowering drugs, eligible dialysis patients are randomized to receive AP301 or a low-dose look-alike comparator three times daily for an initial 8-week double-blind period. Following that, participants receive open-label AP301 for 24 weeks and then enter a short final treatment period, with regular blood tests and safety monitoring throughout. Key outcomes include change in serum phosphate, serum calcium, calcium-phosphate product, intact parathyroid hormone, adverse events, and quality of life measures in the Chinese cohort. The trial enrolls patients aged 12 and older who have been on dialysis for at least three months and meet predefined phosphate and dialysis adequacy thresholds.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Provision of signed and dated ICF
* Age ≥ 12 years when signing the ICF
* Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
* For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
* Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:

  1. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
  2. After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)

Key Exclusion Criteria:

* History or plan of kidney transplantation
* History or plan of parathyroid intervention 6 months before signing the ICF
* Serum calcium \< 1.9 mmol/L (7.6 mg/dL) or \> 2.75 mmol/L (11 mg/dL) at screening
* Serum intact parathyroid hormone \> 127 pmol/L (1200 pg/mL) at screening
* Presence of clinically significant gastrointestinal (GI) disorder
* History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
* Known allergic to any ingredient of AP301, or known history of severe allergies leading to emergency medical care
* Female who are breastfeeding

Where it's running

• Renal Consultants Medical Group
  Granada Hills, California, United States Recruiting
• North America Research Institute - San Dimas
  San Dimas, California, United States Recruiting
• North America Research Institute - San Dimas
  San Dimas, California, United States Recruiting
• Rocky Mountain Kidney Care - Lone Tree
  Lone Tree, Colorado, United States Recruiting
• PACT Kidney Care - Orange
  Orange, Connecticut, United States Recruiting
• US Renal Care - Fort Myers South
  Fort Myers, Florida, United States Recruiting

Study contacts

• Study coordinator: Weifeng Zhang, M.D.
• Email: weifeng.zhang@alebund.com
• Phone: +8618602184576

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Laser acupuncture for fatigue in adults on hemodialysis

  This trial tests whether low-level laser acupuncture can reduce fatigue and improve quality of life for adults with end-stage kidney disease who are on regular hemodialysis, compared with a sham treatment.

  Recruiting Taipei City Hospital · Taipei · NCT07538310

• Italian Registry of Pediatric Dialysis: collecting data from kids on kidney replacement therapy

  This registry in Italy tests how collecting epidemiological, clinical, and treatment data from children on dialysis or pre-emptive kidney transplants can help centers share protocols and improve care.

  Recruiting at 12 sites Istituto Giannina Gaslini · Ancona and 11 other locations · NCT07918066

• 3D Ultrasound Support for Hemodialysis Cannulation

  This study tests whether the EchoMap device can help safely cannulate an arm fistula during hemodialysis for adults.

  Recruiting at 3 sites Sonavex, Inc. · Hartford, Connecticut and 2 other locations · NCT07891741

• Effect of pHA130 Hemoadsorption with Hemodialysis in Kidney Failure

  Aims to see if adding the pHA130 hemoadsorption cartridge to dialysis helps reduce protein-bound toxins in people with end-stage kidney failure on maintenance dialysis.

  Recruiting China-Japan Friendship Hospital · Beijing · NCT07656168

• Low-intensity versus standard-intensity continuous dialysis for critically ill adults with acute kidney injury

  This will try giving lower-intensity continuous dialysis instead of the usual intensity to adults in intensive care with acute kidney injury to see if kidneys recover just as well with fewer side effects.

  Recruiting Guy's and St Thomas' NHS Foundation Trust · London, Greater London · NCT07447791

• Epidemiology and care for dialysis in ICU patients with severe acute kidney injury in Latin America

  This project will collect and compare data on adults in ICUs across Latin America who need dialysis for severe acute kidney injury to see how they are treated and what outcomes they have.

  Recruiting at 8 sites University of Alabama at Birmingham · Cochabamba and 14 other locations · NCT07262320

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.