A Phase 3 interventional study of AP301 and AP301 Low Dose in Hyperphosphatemia, Chronic Kidney Disease, Receiving Dialysis and ESRD (End-Stage Renal Disease), sponsored by Alebund Pharmaceuticals. Recruiting at 42 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.
Sponsored by Alebund Pharmaceuticals · Phase 3, Interventional, and Treatment
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:
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:
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.
173 studies on the registry are indexed under Hyperphosphatemia; 16 are open to participants now.
This study's planned enrollment of 264 is above the median of 101 across 143 interventional studies indexed under Hyperphosphatemia.
Browse Hyperphosphatemia studies →Alebund Pharmaceuticals is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Patients who receive phosphate-lowering drugs over 4 weeks and their serum phosphate level is:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood phosphate-lowering medication containing iron
Drug: AP301
A blood phosphate-lowering medication containing iron, but with a low dose considered as ineffective
Drug: AP301 Low Dose
Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g
Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g
Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups
The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.
Time frame: From Baseline to the end of Week 8
Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups
The amount of phosphate in the blood will be measured with a standard laboratory test. The change in phosphate levels will be compared between the group receiving AP301 maintenance dose and the group receiving AP301 low dose.
Time frame: From the beginning of Week 33 to the end of Week 35
Change in serum phosphate concentrations over time throughout the study
Time frame: From Baseline to the end of Week 35
Change in serum calcium (Ca) and intact parathyroid hormone levels over time
The amount of calcium and intact parathyroid hormone (iPTH) in the blood will be measured with standard laboratory tests.
Time frame: From Baseline to the end of Week 35
Number of adverse events
Time frame: From Baseline to Follow-up (Up to 37 weeks)
Change in QT intervals measured by 12-lead electrocardiagram test over time
The duration of QT intervals will be measured with a standard 12-lead electrocardiagram test.
Time frame: From Baseline to the end of Week 35
Change in the health-related quality of life questionnaires of EQ-5D-5L in Chinese patients only
The change in the scores of the questionnaire EuroQol 5-Dimension 5-Level (EQ-5D-5L), including the health state index score (the higher, the better quality of life) and the visual anaglog scale (ranging from 0 to 100; the higher, the better quality of life).
Time frame: From Baseline to Week 33
Change in the health-related quality of life questionnaires of KDQoL-36 in Chinese only
The change in the scores of the questionnaire Kidney Disease Quality of Life 36-item short form (KDQoL-36). The score ranges from 0 to 100 for five domains, with higher scores indicating better quality of life.
Time frame: From Baseline to Week 33
Started Jun 2025 (actual). Primary completion is estimated for Jun 2026, 12 months after the start.
Of 21 phase 3 interventional studies under Hyperphosphatemia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 22. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: AP301 peptide
Alebund Pharmaceuticals