Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)

Starting soon · Phase 4

Conditions studied: Chronic Kidney Disease, Type 2 Diabetes

In brief

The goal of this clinical trial is to learn if starting four kidney disease medicines quickly and together (a rapid treatment approach) is safe and works well in people with type 2 diabetes and chronic kidney disease. The main questions it aims to answer are: * Is it safe to start these medicines over a short period of time? * How often do kidney function changes or high potassium levels occur? * Does this approach lower protein in the urine (a sign of kidney damage)? * How many participants are able to stay on all four medicines over 6 months? Researchers will compare this approach to usual care, where medicines are started one at a time over several months. Participants will: Be assigned by chance to either this approach or usual care Start up to four approved kidney medicines over about 8 weeks (rapid treatment approach) or follow standard care Have regular clinic visits and lab tests to check kidney function and potassium levels Be followed for about 6 months

Key facts

Study ID

NCT07547878

Run by

Baylor Research Institute

People needed

64

Starts

2026-04-30

Expected to finish

2029-03-31

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18-84 years
• eGFR 45 to ≤90 mL/min/1.73 m2
• UACR >200 mg/g
• diagnosis of T2D
• 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.

You may not qualify if…

• 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)
• predicted 12-month risk of hypoglycemia related emergency visits or hospitalizations >5% using the Kaiser Permanente hypoglycemia prediction score
• high dose insulin use (>1 unit/kg/day).
• RASi: hyperkalemia or angioedema
• SGLT2i: diabetic ketoacidosis, type 1 diabetes, recurrent genitourinary infections
• ns-MRA: hyperkalemia
• GLP1-RA: personal or family history of medullary thyroid carcinoma, known gastroparesis, or pancreatitis.

Where it is running

• Baylor Scott and White Medical Center- Temple — Temple, Texas, United States

Full record on ClinicalTrials.gov

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