A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AP301, AP301 Low Dose.
- Who it may be relevant to
- Registry conditions: Hyperphosphatemia, Chronic Kidney Disease, Receiving Dialysis, ESRD (End-Stage Renal Disease), Dialysis. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug AP301
Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g - Drug AP301 Low Dose
Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g
Primary outcome measures
- Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups [Time frame: From Baseline to the end of Week 8]
Secondary outcome measures (5)
- Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups [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 [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 [Time frame: From Baseline to the end of Week 35]
Eligibility criteria
Inclusion criteria
- Provision of signed and dated ICF
- Age ≥ 12 years 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-lowering drugs over 4 weeks and their serum phosphate level is:
- Screening: 1.13 mmol/L (3.5 mg/dL) ≤ serum phosphate < 2.58 mmol/L (8.0 mg/dL)
- After washout: 1.94 mmol/L (6.0 mg/dL) ≤ serum phosphate < 3.23 mmol/L (10.0 mg/dL)
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 23 centers
- Peking University First Hospital — Beijing
- Beijing Tsinghua Chang Gung Hospital — Beijing
- Peking University International Hospital — Beijing
- The First Affiliated Hospital of Xiamen University — Xiamen
- Henan Provincial People's Hospital — Zhengzhou
- Zhengzhou University-First Affiliated Hospital — Zhengzhou
- Huazhong University of Science and Technology-Tongji Medical College - Wuhan Union Hospita — Wuhan
- Wuhan University People's Hospital — Wuhan
- … and 15 more centers
United States · 19 centers
- Renal Consultants Medical Group — Granada Hills
- North America Research Institute - San Dimas — San Dimas
- North America Research Institute - San Dimas — San Dimas
- Rocky Mountain Kidney Care - Lone Tree — Lone Tree
- PACT Kidney Care - Orange — Orange
- US Renal Care - Fort Myers South — Fort Myers
- Nephrology & Hypertension Specialists — Dalton
- Renal Associates Of Baton Rouge, LLC — Baton Rouge
- … and 11 more centers
Identifiers
NCT: NCT06933472 · AP301-HP-03