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Recruiting Phase 3 Interventional

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

ClinicalTrials.gov ID: NCT06933472

Public ClinicalTrials.gov record NCT06933472. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 5, 2026, 5:38 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Multi-Regional, Phase 3 Study to Evaluate the Efficacy and Safety of AP301 on Serum Phosphorus Control in Chronic Kidney Disease Patients Receiving Maintenance Dialysis With Hyperphosphatemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The goal of this clinical trial is to learn if AP301 could work in the patients receiving maintenance dialysis with elevated blood phosphate. The main questions it aims to answer are: * Does AP301 lower blood phosphate levels? * Does AP301 works on serum calcium level, calcium times phosphate level, and intact parathyroid hormone level? * What discomfort or medical problem do the patients have when taking AP301? * Does AP301 improve quality of life in Chinese patients? The researchers will compare AP301 to an ineffective comparator (a look-alike substance that contains low dose AP301) to see if AP301 works to treat elevated blood phosphate. In the study, the patients will experience the following stages in a chronicle order: * Stop all using blood phosphate-lowering drugs, * Take AP301 or the comparator three times a day for 8 weeks, * Take AP301 three times a day for 24 weeks, and * Take AP301 or the comparator three times a day for 3 weeks. In the first 32 weeks, the dose of AP301 will be adjusted upwards or downwards based on the patient's blood phosphate level and the study doctor's judgment. If the participant has a blood phosphate level above or below a certain level, they may receive additional treatment to lower the blood phosphate level.

Study identification

NCT ID
NCT06933472
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alebund Pharmaceuticals
Industry
Enrollment
264 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
12 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 12, 2025
Primary completion
Jun 19, 2026
Completion
Jan 9, 2027
Last update posted
Jan 28, 2026

2025 – 2027

United States locations

U.S. sites
18
U.S. states
11
U.S. cities
17
Facility City State ZIP Site status
Renal Consultants Medical Group Granada Hills California 91344 Recruiting
North America Research Institute - San Dimas San Dimas California 91773 Recruiting
Rocky Mountain Kidney Care - Lone Tree Lone Tree Colorado 80124 Recruiting
PACT Kidney Care - Orange Orange Connecticut 06477 Recruiting
US Renal Care - Fort Myers South Fort Myers Florida 33912 Recruiting
Nephrology & Hypertension Specialists Dalton Georgia 30720 Recruiting
Renal Associates Of Baton Rouge, LLC Baton Rouge Louisiana 70808 Recruiting
Nephrology Associates, P.C. - Columbus Columbus Mississippi 38801 Recruiting
Nephrology & Hypertension Associates Ltd - Tupelo Tupelo Mississippi 38801 Recruiting
High Desert Nephrology Association - US Renal Care Gallup New Mexico 87301 Recruiting
US Renal Care - West Cheektowaga Cheektowaga New York 14215 Recruiting
NY Kidney & Hypertension Medicine Ridgewood New York 11385 Recruiting
US Renal Care - Alexis Toledo Ohio 43613 Recruiting
Dallas Renal Group - Dallas Dallas Texas 75237 Recruiting
US Renal Care - Bluebonnet Fort Worth Texas 76110 Recruiting
Gamma Medical Research McAllen Texas 78503 Recruiting
US Renal Care - South San Antonio San Antonio Texas 78211 Recruiting
US Renal Care - Hill Country San Antonio Texas 78251 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06933472, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 28, 2026 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06933472 live on ClinicalTrials.gov.

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