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A Study of AP301 for High Phosphate Levels in Dialysis Patients

This study is testing a new medication called AP301 for people with hyperphosphatemia (high phosphate levels in the blood) who are on dialysis for chronic kidney disease or end-stage renal disease. Researchers want to see if AP301 can lower blood phosphate levels, affect calcium and parathyroid hormone levels, and improve quality of life for Chinese patients. You would take AP301 orally three times a day with meals. The study will compare AP301 to a very low dose of AP301 to understand its effects. To join, you must be at least 12 years old, have been on dialysis for at least 3 months, and have high phosphate levels despite taking other phosphate-lowering drugs.

Study design
This interventional study plans to enroll 264 participants. It compares different doses of AP301 to see if it works to treat high blood phosphate.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in serum phosphate concentrations from baseline to the end of Week 8.

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NCT06933472

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Recruiting
PHASE3Ages 12+InterventionalTreatment
Alebund Pharmaceuticals
~264 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:AP301AP301 Low Dose

At a glance

Recruiting sites
41 of 42 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups
Measured over From Baseline to the end of Week 8

Conditions

Hyperphosphatemia
Chronic Kidney Disease, Receiving Dialysis
ESRD (End-Stage Renal Disease)
Dialysis

Explore related trials

Chronic Kidney DiseaseHyperphosphatemia

Where it's being run

42 sites across 21 states
Texas5
Jiangsu5
Shanghai Municipality5
California3
Beijing Municipality3
Mississippi2
New York2
Henan2

Who to contact

Weifeng Zhang, M.D.
[email protected]
+8618602184576
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:

Exclusion

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

What this trial measures

  • Change in serum phosphate concentrations in the AP301 and the AP301 low dose groupsFrom Baseline to the end of Week 8

    The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.