Actively Recruiting
A Randomized, Double-Blind, Multi-Regional Phase 3 Study Evaluating AP301 for Serum Phosphorus Control in Dialysis Patients with Hyperphosphatemia
Led by Alebund Pharmaceuticals · Updated on 2026-01-29
264
Participants Needed
42
Research Sites
29 weeks
Total Duration
On this page
Sponsors
A
Alebund Pharmaceuticals
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating AP301, a novel iron-based phosphate binder, in patients with chronic kidney disease who are receiving maintenance dialysis and have elevated blood phosphate levels. This phase 3, randomized, double-blind study aims to determine whether AP301 lowers blood phosphate and how it affects serum calcium, calcium times phosphate, and intact parathyroid hormone levels. The trial also assesses any discomfort or medical problems during treatment and its impact on quality of life in Chinese patients. Participants will first stop all phosphate-lowering medications. They will then take either AP301 or a low-dose comparator considered ineffective three times daily for 8 weeks. Following this, all participants receive AP301 three times daily for 24 weeks, with dose adjustments based on blood phosphate levels and physician judgment. Finally, participants will take either AP301 or the comparator three times daily for 3 weeks. Additional treatments may be given if blood phosphate levels become too high or low. During the study, participants will undergo regular assessments including blood tests to monitor serum phosphate, calcium, and parathyroid hormone levels. Electrocardiogram tests will measure changes in QT intervals. Safety is monitored by tracking adverse events throughout the trial, which lasts up to 37 weeks. The primary outcome is the change in serum phosphate concentration from baseline to the end of week 8, with ongoing evaluations over the entire study period.
CONDITIONS
Brief Title
A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Age 12 years or older at signing
- Receiving dialysis for at least 3 months before and during the study
- For hemodialysis patients, spKt/V ≥ 1.2; for peritoneal dialysis patients, total Kt/V ≥ 1.7/week
- Serum phosphate levels within 1.13 to 2.58 mmol/L (3.5 to 8.0 mg/dL) at screening
- After washout, serum phosphate levels between 1.94 and 3.23 mmol/L (6.0 to 10.0 mg/dL)
You will not qualify if you...
- History or plans for kidney transplantation
- History or plans for parathyroid intervention within 6 months before signing consent
- Serum calcium below 1.9 mmol/L (7.6 mg/dL) or above 2.75 mmol/L (11 mg/dL) at screening
- Serum intact parathyroid hormone above 127 pmol/L (1200 pg/mL) at screening
- Presence of significant gastrointestinal disorders
- History of gastrectomy, duodenectomy, or gastrointestinal surgery within 3 months before signing consent
- Known allergy to any AP301 ingredient or severe allergy history requiring emergency care
- Females who are breastfeeding
Research Team
W
Weifeng Zhang, M.D.
B
Bobby Zang
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