NCT05764590

A Study to Evaluate Safety and Efficacy of AP-306 in Hyperphosphatemia Patients

A Phase 2, Randomized, Open-Label, Active-Controlled, Multicenter Study to Evaluate the Safety and Serum Phosphorus Lowering Effect of AP-306 in Chronic Kidney Disease Patients Receiving Maintenance Hemodialysis With Hyperphosphatemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Alebund Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the following questions in the patients receiving maintenance hemodialysis with elevated blood phosphorus: * How much effect AP-306 has assessed by blood phosphorus lowering; * How safe and tolerable AP-306 is. Participants will receive either following treatments: * AP-306, and * Sevelamer carbonate.

Conditions

• Chronic Kidney Diseases
• Hyperphosphatemia

Interventions

Type	Name	Description
DRUG	AP-306	A blood phosphorus lowering drug with a novel mechanism
DRUG	Sevelamer Carbonate	A phosphate binder

Timeline

• Start date: 2023-02-20
• Primary completion: 2023-08-25
• Completion: 2023-09-14
• First posted: 2023-03-10
• Last updated: 2024-01-10

Locations

1 site across 1 country: China