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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05764590

Enrollment

Registered

2023-03-10

Start date

2023-02-20

Completion date

2023-09-14

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Hyperphosphatemia

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.

Interventions

DRUGAP-306

A blood phosphorus lowering drug with a novel mechanism

DRUGSevelamer Carbonate

A phosphate binder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

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

Other

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026