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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Baylor Research Institute
- Enrollment
- 64
- Locations
- 1
Study Overview
Brief 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
Detailed Description
This study is a pilot, open-label, randomized clinical trial designed to evaluate the feasibility, safety, and effectiveness of rapidly starting multiple guideline-recommended therapies in people with type 2 diabetes and chronic kidney disease.
In current clinical practice, these medicines are usually started one at a time over many months. This step-by-step approach may delay potential benefits and leave people at continued risk of kidney disease progression and cardiovascular complications. This study will test a different approach, where these therapies are started in a structured and closely monitored way over a short period of time.
Participants will be randomly assigned to either a rapid initiation strategy or usual care. In the rapid group, up to four approved therapies will be started and adjusted over approximately 8 weeks using a structured treatment plan. In the usual care group, treatment will follow standard clinical practice, where medications are introduced gradually at the discretion of the treating clinician.
Participants in both groups will be followed for 6 months. During this time, they will have regular clinic visits and laboratory testing to monitor kidney function, potassium levels, and overall treatment tolerance.
This pilot study will provide important information on whether this rapid treatment approach can be safely implemented in real-world clinical settings and whether participants are able to start and continue multiple therapies within a short time frame.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 84 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.