A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Официальное название

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

Обзор

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.

Вмешательства

• Препарат AP301
  Three times a day, administered orally with three meals at a daily dose level from 2.7g to 9.0g
• Препарат AP301 Low Dose
  Three times a day, administered orally with three meals at a daily dose level from 0.075g to 0.25g

Первичные конечные точки

• Change in serum phosphate concentrations in the AP301 and the AP301 low dose groups [Срок оценки: From Baseline to the end of Week 8]

Вторичные конечные точки (5)

• Chang in serum phosphate concentrations in the AP301 maintenance dose and the AP301 low dose groups [Срок оценки: From the beginning of Week 33 to the end of Week 35]
• Change in serum phosphate concentrations over time throughout the study [Срок оценки: From Baseline to the end of Week 35]
• Change in serum calcium (Ca) and intact parathyroid hormone levels over time [Срок оценки: From Baseline to the end of Week 35]
• Number of adverse events [Срок оценки: From Baseline to Follow-up (Up to 37 weeks)]
• Change in QT intervals measured by 12-lead electrocardiagram test over time [Срок оценки: From Baseline to the end of Week 35]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 23 центра

• Peking University First Hospital — Пекин
• Beijing Tsinghua Chang Gung Hospital — Пекин
• Peking University International Hospital — Пекин
• The First Affiliated Hospital of Xiamen University — Xiamen
• Henan Provincial People's Hospital — Чжэнчжоу
• Zhengzhou University-First Affiliated Hospital — Чжэнчжоу
• Huazhong University of Science and Technology-Tongji Medical College - Wuhan Union Hospita — Ухань
• Wuhan University People's Hospital — Ухань
• … и ещё 15 центров

США · 19 центров

• 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
• … и ещё 11 центров

Идентификаторы

NCT: NCT06933472 · AP301-HP-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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