A Phase 3 interventional study of AP301 and Sevelamer carbonate (Renvela®) in ESRD (End Stage Renal Disease), Chronic Kidney Disease(CKD) and Hyperphosphatemia, sponsored by Alebund Pharmaceuticals. Completed at 50 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Alebund Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's enrollment of 474 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Alebund Pharmaceuticals is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Key Inclusion Criteria:
For patients who receive phosphate binders and their serum phosphate level is:
For patients who do not receive phosphate binders over 2 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 marketed blood phosphate-lowering medication
Drug: Sevelamer carbonate (Renvela®)
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 2.1g to 9.1g
Three times a day, administered orally with three meals at a daily dose level from 2.4g to 9.6g
Three times a day, administered orally with three meals at a daily dose level of 0.375g.
Change in serum phosphorus levels between AP301 and AP301 low dose groups in hyperphosphatemic patients
The serum phosphorus will be measured with a standard laboratory test. The change in serum phosphorus levels will be compared between the group receiving AP301 and the group receiving AP301 low dose.
Time frame: From the end of Week 24 to the end of Week 27
Change in serum phosphorus levels between AP301 and sevelamer carbonate groups in hyperphosphatemic patients
The serum phosphorus will be measured with a standard laboratory test. The change in serum phosphorus levels will be compared between the group receiving AP301 and the group receiving sevelamer carbonate.
Time frame: From Baseline to the end of Week 12
The achievement rate of serum phosphorus in the target range 1.13-1.78 mmol/L (3.5-5.5 mg/dL) (both inclusive).
The serum phosphorus will be measured with a standard laboratory test.
Time frame: From Baseline to the end of Week 52.
Changes in serum calcium
The serum calcium in the blood will be measured with a standard laboratory test.
Time frame: From Baseline to the end of Week 52
Changes in serum calcium times phosphorus product
The serum calcium and phosphorus in the blood will be measured with standard laboratory tests.
Time frame: From Baseline to the end of Week 52
Changes in intact parathyroid hormone
The intact parathyroid hormone in the blood will be measured with a standard laboratory test.
Time frame: From Baseline to the end of Week 52
Changes in serum bone-specific alkaline phosphatase
The serum bone-specific alkaline phosphatase in the blood will be measured with standard laboratory tests.
Time frame: From Baseline to the end of Week 52
Changes in osteocalcin
The serum osteocalcin in the blood will be measured with a standard laboratory test.
Time frame: From Baseline to the end of Week 52
Number of adverse events
Time frame: From Baseline to Follow-up (up to 54 weeks)
Changes in serum iron parameters
The serum iron parameters will be measured with standard laboratory tests.
Time frame: From Baseline to the end of Week 52
Change in QT intervals measured by 12-lead electrocardiogram test over time
The duration of QT intervals will be measured with a standard 12-lead electrocardiogram test.
Time frame: From Baseline to the end of Week 52
Number of participants with abnormal vital signs
The vital sign will consist of pulse rate and blood pressure with standard measurements.
Time frame: From Baseline to the end of Week 52
Number of participants with abnormal laboratory tests results
The laboratory tests will be measured with standard validated methods, involving hematology, biochemistry, bone markers, iron parameters and others.
Time frame: From Baseline to the end of Week 52
Changes in average serum phosphorus levels
The serum phosphorus will be measured with a standard laboratory test.
Time frame: From the end of Week 48 to the end of Week 52
Number of adverse events
Time frame: From the end of Week 48 to the end of Week 52
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AP301 peptide
Renal Insufficiency, Chronic →
Alebund Pharmaceuticals