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).