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

NCT ID: NCT05764590

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2023-09-14

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AP-306

Group Type: EXPERIMENTAL

AP-306

Intervention Type: DRUG

A blood phosphorus lowering drug with a novel mechanism

Sevelamer Carbonate

Group Type: ACTIVE_COMPARATOR

Sevelamer Carbonate

Intervention Type: DRUG

A phosphate binder

Interventions

AP-306

A blood phosphorus lowering drug with a novel mechanism

Intervention Type: DRUG

Sevelamer Carbonate

A phosphate binder

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alebund Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Sichuan Provincial People's Hospital

Locations

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

AP306-HP-01

Identifier Type: -

Identifier Source: org_study_id