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Активно (без набиране) Фаза 4 NCT07547878

Simultaneous Starting of the 4 Guideline Directed CKD Therapies (RAPID-CKD)

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Chronic Kidney Diseases Type 2 Diabetes

Спонсор: Baylor Research Institute

Налично на: БГ
Обобщение
The purpose of this study is to determine if starting all four chronic kidney disease therapies at the same time is safe and effective in patients with Type 2 Diabetes and Chronic Kidney Disease. Study hypothesis states that starting all four recommended kidney medications at the same time is safe and effective in reducing albuminuria, a protein in the urine, without a decline in kidney function or increase in potassium levels compared to starting one medication at a time.
Кой може да участва
Inclusion Criteria: * Patients aged 18-84 years * eGFR 45 to ≤90 mL/min/1.73 m2 * UACR \>200 mg/g * diagnosis of T2D30 * receiving ≤2 guideline-recommended drug classes irrespective of dose for ≥4 weeks prior to screening * eligible for all 4 drugs * systolic BP (SBP) \>90 mmHg * those willing to provide written informed consent and to adhere to study visits. Exclusion Criteria: * Type 1 diabetes * any known primary non-diabetic kidney disease (i.e., polycystic kidney disease, glomerulonephritis, interstitial nephritis, etc.) * history of kidney transplant * liver disease (i.e., aspartate transaminase or alanine transaminase \>5 times, or bilirubin \>3 times the upper limit of normal) * serum potassium \>5.5 mEq/L at baseline * known hypersensitivity to any study drug * life expectancy \<6 months * active malignancy or infection * brittle diabetes (defined as severe glycemic instability with hospitalization or emergency care for hypoglycemia or hyperglycemia within the past 6 months) * high-risk of hypoglycemia (Clarke or Gold score ≥4)31 * predicted 12-month risk of hypoglycemia related emergency visits or hospitalizations \>5% using the Kaiser Permanente hypoglycemia prediction score32,33 * high dose insulin use (\>1 unit/kg/day).
Интервенции
Finerenone
DRUG
Semaglutide
DRUG
Lotensin
DRUG
Capoten
DRUG
Enalapril
DRUG
Monopril
DRUG
Lisinopril
DRUG
Univasc
DRUG
Aceon
DRUG
Accupril
DRUG
Altace
DRUG
Mavik
DRUG
Edarbi
DRUG
Atacand
DRUG
Avapro
DRUG
Cozaar
DRUG
Benicar
DRUG
Micardis
DRUG
Diovan
DRUG
Invokana
DRUG
Farxiga
DRUG
Jardiance
DRUG
Ertugliflozin
DRUG
Brenzavvy
DRUG
Sotagliflozin
DRUG
Места на провеждане 1
САЩ (1)
Baylor Scott and White Medical Center- Temple
Temple , Texas
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
84 Years
Здрави доброволци
Не
Начална дата
09.04.2026
Крайна дата
31.03.2029
Регистрационен номер
NCT07547878
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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