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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
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.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Renal Consultants Medical Group
Granada Hills, California, United States
North America Research Institute - San Dimas
San Dimas, California, United States
North America Research Institute - San Dimas
San Dimas, California, United States
Rocky Mountain Kidney Care - Lone Tree
Lone Tree, Colorado, United States
PACT Kidney Care - Orange
Orange, Connecticut, United States
US Renal Care - Fort Myers South
Fort Myers, Florida, United States
Nephrology & Hypertension Specialists
Dalton, Georgia, United States
Renal Associates Of Baton Rouge, LLC
Baton Rouge, Louisiana, United States
Nephrology Associates, P.C. - Columbus
Columbus, Mississippi, United States
Nephrology & Hypertension Associates Ltd - Tupelo
Tupelo, Mississippi, United States
Start Date
June 13, 2025
Primary Completion Date
June 20, 2026
Completion Date
January 10, 2027
Last Updated
January 29, 2026
264
ESTIMATED participants
AP301
DRUG
AP301 Low Dose
DRUG
Lead Sponsor
Alebund Pharmaceuticals
Collaborators
NCT07224763
NCT05085275
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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