Идёт набор NCT06712654

A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia

Фаза II С лечением Hyperphosphatemia Chronic Kidney Disease Requiring Chronic Dialysis End Stage Renal Disease on Dialysis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: AP306 75 mg BID, AP306 125 mg BID, AP306 150 mg BID, AP306 75 mg TID.
Кому может быть актуально: Состояния в реестре: Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis, End Stage Renal Disease on Dialysis. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Serum Phosphate Lowering Effect of Fixed Dose AP306 in Participants With Hyperphosphatemia Receiving Maintenance Hemodialysis

Обзор

This study is being conducted to characterize the safety, tolerability, and efficacy of AP306 at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.

Подробное описание

Hyperphosphatemia, one of the most common complications of advanced chronic kidney disease, becomes increasingly prevalent as kidney function declines and is found almost universally in patients with end-stage kidney disease requiring dialysis. Hyperphosphatemia is an independent risk factor for cardiovascular outcomes, fractures, and mortality in patients with chronic kidney disease, especially in patients receiving dialysis.

AP306 is a pan-phosphate transporter inhibitor that may stop phosphate absorption in the gut, controlling hyperphosphatemia.

This is a randomized, double-blind, placebo-controlled, study to characterize the safety, tolerability, and efficacy of AP306 given daily for 8 weeks at fixed doses in adults with hyperphosphatemia receiving maintenance hemodialysis.

Вмешательства

Препарат AP306 75 mg BID
AP306 75 mg by mouth, twice daily (150 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
Препарат AP306 125 mg BID
AP306 125 mg by mouth, twice daily (250 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
Препарат AP306 150 mg BID
AP306 150 mg by mouth, twice daily (300 mg/day). Placebo given once daily. Treatment given daily for 8 weeks.
Препарат AP306 75 mg TID
AP306 75 mg by mouth, three times daily (225 mg/day). Treatment given daily for 8 weeks.
Препарат AP306 100 mg TID
AP306 100 mg by mouth, three times daily (300 mg/day). Treatment given daily for 8 weeks.
Препарат AP306 125 mg TID
AP306 125 mg by mouth, three times daily (375 mg/day). Treatment given daily for 8 weeks.
Препарат Placebo
Placebo given by mouth, three times daily. Treatment given daily for 8 weeks.

Первичные конечные точки

To investigate the ability of AP306 at different fixed doses to lower serum phosphate in participants with hyperphosphatemia receiving maintenance hemodialysis [Срок оценки: 8 weeks]

Вторичные конечные точки (3)

To assess the proportion of participants with serum phosphate in the target range [Срок оценки: 8 weeks]
To assess the change in serum phosphate from baseline to the end of the Treatment Period [Срок оценки: 8 weeks]
To assess the time to response on serum phosphate reduction [Срок оценки: 8 weeks]

Критерии участия

Important Inclusion Criteria:

Signs a written informed consent form (ICF) and is willing to comply with all study requirements in the study
Receiving a stable hemodialysis (including hemodialysis, hemodiafiltration, and hemoadsorption) regimen, which is defined as a frequency of three times per week for at least 12 weeks before signing the ICF, and does not plan to change in the study
Who has a blood phosphate level within the study-required range
Who has a dialysis adequacy, assessed by single pooled Kt/V (SpKt/V, estimated with blood urea) ≥1.20, at screening or any documented value ≥1.20 within 12 weeks prior to signing the ICF
If the participant is receiving etelcalcetide, their doses must be unchanged for at least 4 weeks prior to signing the ICF
If the participant is receiving any of the following therapies, their doses are stable for at least 14 days prior to signing the ICF: phosphate-lowering products other than tenapanor or phosphate binders, active vitamin D and analogs, cinacalcet, calcitonin, and P-glycoprotein inhibitors
Agreement to use highly effective contraception for women of childbearing potentially and non-sterile sexually active males throughout the study and for 90 days after the final dose of study drug

Important Exclusion Criteria:

Pregnant or breastfeeding
Scheduled for a living donor kidney transplant in the next 6 months, planned change to peritoneal dialysis or home hemodialysis in the study; planned relocation to another dialysis center in the study
Any history of a non-pharmacological parathyroid intervention within 6 months prior to the ICF sign off, or planned parathyroid intervention in the study
Blood calcium or blood intact parathyroid hormone abnormality
Adequate organ and bone marrow function
Acute hepatitis or significant chronic liver disease
Any clinically significant GI disorders within 4 weeks prior to signing the ICF; or any history of gastrectomy; or any GI tract surgery (excluding appendectomy and polypectomy), within 12 weeks of signing the ICF
Uncontrolled hypertension
Hospitalization for cardiac or cardiocerebrovascular disease within 24 weeks prior to signing the ICF
Significant abnormalities of QT interval and heart rhythm on an electrocardiograph (ECG) test
Any clinically significant active infection or infestation or any treatment with systemic antimicrobial treatment within 2 weeks prior to signing the ICF
History or presence of malignancy within 3 years prior to signing the ICF, except basal cell skin cancer, in-situ carcinoma of the cervix, and in-situ prostate cancer
Taking moderate or strong cytochrome P450 (CYP) 3A inhibitors within 2 weeks or 5 half-lives, whichever is longer, prior to signing the ICF (topical use is allowed)
Treatment with any investigational medication or medical device within 30 days prior to signing the ICF
Life expectancy less than 12 months

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

Здоровые добровольцы: Нет