Clinical trial NCT06933472: A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hyperphosphatemia
Chronic Kidney Disease, Receiving Dialysis
ESRD (End-Stage Renal Disease)
Dialysis
Keywords: Hyperphosphatemia
AP301
Dialysis
ESKD
Lead sponsor: Alebund Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Fortrea
First posted: 2025-04-18
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key 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
* Patients who receive phosphate binders over 4 weeks 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)

Key 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 \> 127 pmol/L (1200 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 known history of severe allergies leading to emergency medical care
* Female who are breastfeeding

Primary outcomes:
measure: Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups
timeFrame: From Baseline to the end of Week 8
Secondary outcomes:
measure: Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups
timeFrame: From the beginning of Week 33 to the end of Week 35
measure: Change in serum phosphate concentrations over time throughout the study
timeFrame: From Baseline to the end of Week 35
measure: Change in serum calcium (Ca) and intact parathyroid hormone levels over time
timeFrame: From Baseline to the end of Week 35
measure: Number of adverse events
timeFrame: From Baseline to Follow-up (Up to 37 weeks)
measure: Change in QT intervals measured by 12-lead electrocardiagram test over time
timeFrame: From Baseline to the end of Week 35
Other outcomes:
measure: Change in the health-related quality of life questionnaires of EQ-5D-5L in Chinese patients only
timeFrame: From Baseline to Week 33
measure: Change in the health-related quality of life questionnaires of KDQoL-36 in Chinese only
timeFrame: From Baseline to Week 33
Locations:
city: Lone Tree
country: United States
facility: Rocky Mountain Kidney Care - Lone Tree
state: Colorado
city: Orange
country: United States
facility: PACT Kidney Care - Orange
state: Connecticut
city: Fort Myers
country: United States
facility: US Renal Care - Fort Myers South
state: Florida
city: Dalton
country: United States
facility: Nephrology & Hypertension Specialists
state: Georgia
city: Cheektowaga
country: United States
facility: US Renal Care - West Cheektowaga
state: New York
city: Toledo
country: United States
facility: US Renal Care - Alexis
state: Ohio
city: San Antonio
country: United States
facility: US Renal Care - South San Antonio
state: Texas
Study officials:
References: