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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Hyperphosphatemia
• Intervention / Treatment: Drug: AP-306; Drug: Sevelamer Carbonate

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Important Inclusion Criteria:

1. On a stable hemodialysis regimen at a frequency of three times per week for at least 12 weeks prior to the screening visit
2. Dialysis sufficiency SpKt/V ≥ 1.2 at the screening visit or any documented result within 12 weeks prior to the screening visit
3. Serum phosphorus within the trial-required range

Important Exclusion Criteria:

1. Pregnant or breastfeeding
2. Any history of kidney transplant
3. Any history of a parathyroid intervention
4. Any clinically significant GI disorders within 4 weeks prior to the screening visit
5. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
6. Hospitalization for cardiac or cerebrovascular disease within 24 weeks prior to the screening visit
7. Documented history of hypersensitivity or allergic reactions to any of the excipients used by AP-306, or history of hypersensitivity or allergic reactions or intolerant to sevelamer carbonate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AP-306	Drug: AP-306; A blood phosphorus lowering drug with a novel mechanism
Active Comparator: Sevelamer Carbonate	Drug: Sevelamer Carbonate; A phosphate binder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the efficacy of AP-306 assessed by serum phosphorus lowering	The change in serum phosphorus level from the baseline to the end of treatment	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the overall safety of AP-306 assessed by incidence of treatment-emergent adverse events	All adverse events occurred after the study treatment initiation will be collected and their nature, frequency, and severity will be assessed.	15 weeks

Collaborators and Investigators

• Sponsor: Alebund Pharmaceuticals
• Investigators: Principal Investigator: Li Wang, MD, Sichuan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Phosphorus Metabolism Disorders; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Sevelamer
• Other Study ID Numbers: AP306-HP-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No