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
Baylor Research Institute
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
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 clos…
Eligibility
- Age range
- 18–84 years
- Sex
- All
- 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 tra…
Interventions
- DrugFinerenone
10-40mg daily
- DrugSemaglutide
.25-1.0mg 1 time a week
- DrugLotensin
10-40mg daily
- DrugCapoten
12.5-50mg 3 times a day
- DrugEnalapril
2.5-10mg daily
- DrugMonopril
10-40mg daily
- DrugLisinopril
5-20mg daily
- Drug
Location
- Baylor Scott and White Medical Center- TempleTemple, Texas