Clinical trial

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

Opening soon · Phase 4 · 1 countries · Registry ID NCT07547878

Opening soonPhase 4Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 84 Years
SexAll
Healthy volunteersNot accepted
ConditionChronic Kidney Disease, Type 2 Diabetes

Full registry criteria

Inclusion Criteria: * 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. 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) * 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.

Treatments and study arms

Finerenone

Drug

10-40mg daily

Semaglutide

Drug

.25-1.0mg 1 time a week

Lotensin

Drug

10-40mg daily

Capoten

Drug

12.5-50mg 3 times a day

Enalapril

Drug

2.5-10mg daily

Monopril

Drug

10-40mg daily

Lisinopril

Drug

5-20mg daily

Univasc

Drug

3.75-15mg daily

Aceon

Drug

4-16mg daily

Accupril

Drug

10-40mg daily

Altace

Drug

1.25-5mg daily

Mavik

Drug

1-4mg daily

Edarbi

Drug

40-80mg daily

Atacand

Drug

8-32mg daily

Avapro

Drug

150-300mg daily

Cozaar

Drug

25-100mg daily

Benicar

Drug

20-40mg daily

Micardis

Drug

20-80mg daily

Diovan

Drug

80-320mg daily

Invokana

Drug

100mg daily

Farxiga

Drug

10mg daily

Jardiance

Drug

10mg daily

Ertugliflozin

Drug

5mg daily

Brenzavvy

Drug

20mg daily

Sotagliflozin

Drug

200-400mg daily

Primary outcomes

On-study retention rate at 6 months6 months

Proportion of participants who remain on all four guideline-directed CKD therapies at maximally tolerated doses without permanent discontinuation

Sustained decline in eGFR ≥30%6 months

Proportion of participants with sustained decline in estimated glomerular filtration rate (eGFR; two consecutive readings ≥2 weeks apart)

Change in UACR6 months

Relative change in log-transformed urine albumin-to-creatinine ratio (UACR) from baseline to 6 months

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Baylor Scott and White Medical Center- Temple🇺🇸 Temple, Texas, United States
Shahzeb Khan, MDContact
Shahzeb Khan, MDPrincipal Investigator