A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

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

CT.gov Identifier
NCT07547878
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
Global Research Institute
Collaborator
N/A
Study Contact Information
N/A
Recruiting
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Study Details

Diseases
Chronic Kidney Disease
Study Drug
Captopril
See More
Benazepril
Trandolapril
Moexipril
Olmesartan medoxomil
Fosinopril/hydrochlorothiazide
Lisinopril + HCTZ
Dapagliflozin
Empagliflozin
Irbesartan
Losartan potassium
Perindopril
Quinapril hydrochloride
Ramipril
Ertugliflozin
Bexagliflozin
Finerenone
Canagliflozin + metformin, immediate-release
Rosuvastatin + valsartan, LG Life Sciences
Enalapril maleate, Siegfried Rhein
Azilsartan, Lee's Pharmaceutical
Telmisartan + amlodipine + indapamide, George Medicines
Semaglutide, Jilin Huisheng Biopharmaceutical
Genes
N/A
Study Dates
Apr 2026 - Mar 2029
Sex
Female & Male
Age
18 - 84 Years
Inclusion and Exclusion 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.

Protocol Summary

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

Study Locations

To view all trial locations, click here

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