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Активно (без набиране) Фаза 3 2024-514135-17-00

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobulin A Nephropathy (RAINIER).

Фаза 3 – широко изпитване преди одобрение
Заболявания: Immunoglobulin A Nephropathy

Спонсор: Alpine Immune Sciences Inc.

Налично на: БГ
Обобщение
Trial status: Authorised 3. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104]., 4. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death. [Time Frame: From Baseline Through Week 104]., 1. Change from baseline in serum Gd-IgA1 at Week 36, 2. Proportion of subjects to achieve hematuria resolution at Week 36 (among subjects with hematuria at baseline) 1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 [Time Frame: From Baseline at Week 36]., 2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 [Time Frame: From Baseline Through Week 104].
Описание
3. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104]., 4. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death. [Time Frame: From Baseline Through Week 104]., 1. Change from baseline in serum Gd-IgA1 at Week 36, 2. Proportion of subjects to achieve hematuria resolution at Week 36 (among subjects with hematuria at baseline)
Кой може да участва
Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 181 participants
Интервенции
ALPN-303 solution for injection
Drug
Test IMP without active substance
Drug
Test IMP ALPN-303 pre-filled syringe without active substance
Drug
ALPN-303 solution for injection in pre-filled syringe
Drug
Места на провеждане 19
Австрия (1)
Белгия (1)
Хърватия (1)
Чехия (1)
Дания (1)
Estonia (1)
Финландия (1)
Франция (1)
Германия (1)
Унгария (1)
Ireland (1)
Италия (1)
Latvia (1)
Lithuania (1)
Нидерландия (1)
Норвегия (1)
Полша (1)
Испания (1)
Швеция (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
11.11.2024
Регистрационен номер
2024-514135-17-00
Източник
euclinicaltrials.eu
Запитване за медицински туризъм

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