Status:
RECRUITING
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Lead Sponsor:
Alebund Pharmaceuticals
Collaborating Sponsors:
Fortrea
Conditions:
Hyperphosphatemia
Chronic Kidney Disease, Receiving Dialysis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP301 lo...
Eligibility Criteria
Inclusion
- Key
- 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:
- Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
- After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)
- Key
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
Key Trial Info
Start Date :
June 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 10 2027
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT06933472
Start Date
June 13 2025
End Date
January 10 2027
Last Update
November 4 2025
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Renal Consultants Medical Group
Granada Hills, California, United States, 91344
2
North America Research Institute - San Dimas
San Dimas, California, United States, 91773
3
North America Research Institute - San Dimas
San Dimas, California, United States, 91773
4
Rocky Mountain Kidney Care - Lone Tree
Lone Tree, Colorado, United States, 80124