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Active (not recruiting) Phase 4 NCT07547878

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

Phase 4 – monitoring after market approval
Conditions: Chronic Kidney Diseases Type 2 Diabetes

Sponsor: Baylor Research Institute

trial.available_in: БГ
Overview
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.
Who can participate
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).
Interventions
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
Locations 1
United States (1)
Baylor Scott and White Medical Center- Temple
Temple , Texas
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
84 Years
Healthy volunteers
No
Start date
09.04.2026
Completion date
31.03.2029
Registry ID
NCT07547878
Source
clinicaltrials.gov
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