Home
Clinical Trials
AP301 Efficacy and Safety in ...

AP301 Efficacy and Safety in Chinese Dialysis Patients With Hyperphosphatemia

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

474 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-12

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This Phase 3 clinical trial is the pivotal study of AP301 aiming to evaluate the efficacy and safety of AP301 for controlling serum phosphorus in chronic kidney disease receiving hemodialysis and peritoneal dialysis in Chinese patients with hyperphosphatemia.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05764590

Chronic Kidney Diseases Hyperphosphatemia

COMPLETED PHASE2

A Comparative Study of ASP1585 in Chronic Kidney Disease Patients With Hyperphosphatemia on Hemodialysis

NCT01057407

Chronic Kidney Disease Renal Dialysis Renal Insufficiency

COMPLETED PHASE3

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

NCT06712654

Hyperphosphatemia Chronic Kidney Disease Requiring Hemodialysis

NOT_YET_RECRUITING PHASE2

A Phase 2 Study to Evaluate the Safety and Efficacy of VS-505(AP301) to Treat Hyperphosphatemia in Hemodialysis Patients

NCT04551300

Hyperphosphatemia

COMPLETED PHASE2

A Randomised, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sevelamer Carbonate Tablets Dosed Three Times a Day in Hyperphosphataemic Chronic Kidney Disease Patients Not on Dialysis

NCT00833768

Chronic Kidney Disease Hyperphosphatemia

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study has two primary efficacy objectives. The primary efficacy objective 1 is to evaluate the superiority of maintenance dose versus low dose of AP301 on serum P control in dialysis patients with hyperphosphatemia. The primary efficacy objective 2 is to evaluate the non-inferiority of AP301 versus sevelamer carbonate on serum phosphorus control. Besides these two primary efficacy objectives, this study will also evaluate the serum phosphorus control equivalence and the safety for AP301 produced from two APIs (Active Pharmaceutical Ingredient) in the last 8 weeks of drug exposure.

Patients will start dosed after eligibility confirmation. The treatment period will last 52 weeks in total, including:

A) A 24-week sevelamer carbonate active control phase in which serum phosphorus level at the end of Week 12 will be measured for the analysis of primary efficacy endpoint 2, B) A 3-week AP301 low dose control phase in which serum phosphorus level at the end of Week 27 will be measured for the analysis of primary efficacy endpoint 1, and C) A 25 or 28-week extension treatment phase

The investigational treatments will be AP301. Sevelamer carbonate will be provided as active control in active control and extension treatment phase and AP301 125 mg as ineffective control in low dose control phase.

A) The starting dose of AP301 is one 700 mg capsule 3 times daily. The dosage is to be adjusted based on their serum phosphorus level and safety assessmentsevery two or four weeks. The maximal dose is to be 10 capsules daily.

B) The starting dose of sevelamer carbonate will be one to two 800 mg capsules 3 times daily. The dosage is to be adjusted based on their serum phosphorus level every and safety assessments two or four weeks. The maximal dose is to be 12 capsules daily.

Then, a 2-week safety observation will be followed after the last dosing.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ESRD (End Stage Renal Disease) Chronic Kidney Disease(CKD) Hyperphosphatemia Hyperphosphatemia in Chronic Kidney Disease Dialysis Chronic Kidney Disease, Receiving Dialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AP301

A blood phosphate-lowering medication containing iron

Group Type EXPERIMENTAL

AP301

Intervention Type DRUG

Three times a day, administered orally with three meals at a daily dose level from 2.1g to 9.1g

Sevelamer Carbonate

A marketed blood phosphate-lowering medication

Group Type ACTIVE_COMPARATOR

Sevelamer carbonate (Renvela®)

Intervention Type DRUG

Three times a day, administered orally with three meals at a daily dose level from 2.4g to 9.6g

AP301 Low Dose

A blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective

Group Type EXPERIMENTAL

AP301 Low Dose

Intervention Type DRUG

Three times a day, administered orally with three meals at a daily dose level of 0.375g.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AP301

Three times a day, administered orally with three meals at a daily dose level from 2.1g to 9.1g

Intervention Type DRUG

Sevelamer carbonate (Renvela®)

Three times a day, administered orally with three meals at a daily dose level from 2.4g to 9.6g

Intervention Type DRUG

AP301 Low Dose

Three times a day, administered orally with three meals at a daily dose level of 0.375g.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Provision of signed and dated ICF
* Adult when signing the ICF
* Patients on dialysis for ≥ 3 months before signing the ICF and throughout the study
* For HD patients, spKt/V ≥ 1.2; for PD patients, total Kt/V ≥ 1.7/week
* For patients who receive phosphate binders and their serum phosphate level is:

1. Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate \< 2.58 mmol/L (8.0 mg/dL)
2. After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)
* For patients who do not receive phosphate binders over 2 weeks and their serum phosphate level is:

1. Screening: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate \< 3.23 mmol/L (10.0 mg/dL)

Exclusion Criteria

* History or plan of kidney transplantation
* History or plan of parathyroid intervention 6 months before signing the ICF
* Serum calcium \< 1.9 mmol/L (7.6 mg/dL) or \> 2.75 mmol/L (11 mg/dL) at screening
* Serum intact parathyroid hormone \> 110 pmol/L (1000 pg/mL) at screening
* Presence of clinically significant gastrointestinal (GI) disorder
* History of gastrectomy or duodenectomy, or GI surgery within 3 months before signing the ICF
* Known allergic to any ingredient of AP301 or Sevelamer Carbonate, or known history of severe allergies leading to emergency medical care
* Female who are breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.