Health TrialsbyHealthPanel

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

ConditionsChronic Kidney DiseaseType 2 Diabetes
Trial statusEnrolling by invitation
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-84
SponsorBaylor Research Institute

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-84 years

eGFR 45 to ≤90 mL/min/1.73 m2

UACR >200 mg/g

diagnosis of T2D

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Interventional GroupActive comparator 25 interventions
Group B: Control GroupActive comparator 25 interventions

Trial outcomes

Primary outcomes

1

On-study retention rate at 6 months

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

Time frame
6 months
2

Sustained decline in eGFR ≥30%

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

Time frame
6 months
3

Change in UACR

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

Time frame
6 months

Secondary outcomes

1

Enrollment rate

Number of participants enrolled per month

Time frame
6 months
2

Protocol adherence

Proportion of participants initiating all four therapies within 8 weeks

Time frame
6 months
3

Treatment discontinuation

Proportion of participants who permanently discontinue one or more therapies

Time frame
6 months
4

Moderate Hyperkalemia

Incidence of potassium levels greater than 5.5 to less than or equal to 6.0 mmol/L

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor Research Institute

Lead sponsor

Source ClinicalTrials.gov
Apply now