NCT06712654

A Study to Evaluate Safety, Tolerability and Efficacy of AP306 At Fixed Doses in Patients with Hyperphosphatemia

A Phase 2b, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Serum Phosphate Lowering Effect of Fixed Dosed AP306 in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Alebund Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if AP306 could work in the patients receiving maintenance hemodialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP306 lower blood phosphate levels when the participants take a fixed dose of AP306? * What medical problems do the participants have when taking AP306? The researchers will compare AP306 to a placebo (a look-alike substance that contains no drug) to see if AP306 works to treat hyperphosphatemia. The participants will: * Stop all using blood phosphate-lowering drugs, and * Take AP306 or a placebo three times a day for 12 weeks. If the participant has a blood phosphate level above a certain level, they will receive additional treatment to lower the blood phosphate level.

Conditions

• Hyperphosphatemia
• Chronic Kidney Disease Requiring Hemodialysis

Interventions

Type	Name	Description
DRUG	AP306 75mg TID	receiving orally AP306 75mg (one tablet), three times a day
DRUG	AP306 100mg TID	receiving orally AP306 100 mg (one tablet), three times a day.
DRUG	AP306 125mg TID	receiving orally AP306 125 mg (one tablet), three times a day
DRUG	AP306 125mg BID	receiving orally AP306 125 mg (one tablet), three times a day, among which one is a placebo tablet
DRUG	AP306 150mg BID	receiving orally AP306 150 mg (one tablet), three times a day, among which one is a placebo tablet
DRUG	Placebo TID	receiving orally one placebo tablet of AP306, three times a day

Timeline

• Start date: 2025-04-10
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2024-12-02
• Last updated: 2024-12-02

Regulatory

• FDA-regulated drug study