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Not yet recruiting NCT07547878

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

Phase IV Interventional Chronic Kidney Disease Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Finerenone, Semaglutide, Lotensin, Capoten.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease, Type 2 Diabetes. Basic parameters: 18 years — 84 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Finerenone
    10-40mg daily
  • Drug Semaglutide
    .25-1.0mg 1 time a week
  • Drug Lotensin
    10-40mg daily
  • Drug Capoten
    12.5-50mg 3 times a day
  • Drug Enalapril
    2.5-10mg daily
  • Drug Monopril
    10-40mg daily
  • Drug Lisinopril
    5-20mg daily
  • Drug Univasc
    3.75-15mg daily
  • Drug Aceon
    4-16mg daily
  • Drug Accupril
    10-40mg daily

Primary outcome measures

  • On-study retention rate at 6 months [Time frame: 6 months]
  • Sustained decline in eGFR ≥30% [Time frame: 6 months]
  • Change in UACR [Time frame: 6 months]
Secondary outcome measures (12)
  • Enrollment rate [Time frame: 6 months]
  • Protocol adherence [Time frame: 6 months]
  • Treatment discontinuation [Time frame: 6 months]
  • Moderate Hyperkalemia [Time frame: 6 months]
  • Severe Hyperkalemia [Time frame: 6 months]
  • Acute Kidney Injury [Time frame: 6 months]
  • End-stage kidney disease [Time frame: 6 months]
  • Number of participants with permanent drug discontinuation [Time frame: 6 months]
  • Rate of change in estimated glomerular filtration rate (slope) [Time frame: 6 months]
  • Change in glycated hemoglobin (HbA1c) [Time frame: 6 months]
  • Number of participants who achieve >30% reduction in urine albumin-to-creatinine ratio [Time frame: 6 months]
  • Change in Kidney Disease Quality of Life-36 score [Time frame: 6 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Baylor Scott and White Medical Center- Temple — Temple

Publications

  • Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl (2011). 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. Epub 2022 Mar 18. PMID 35529086
  • Dalrymple LS, Katz R, Kestenbaum B, Shlipak MG, Sarnak MJ, Stehman-Breen C, Seliger S, Siscovick D, Newman AB, Fried L. Chronic kidney disease and the risk of end-stage renal disease versus death. J Gen Intern Med. 2011 Apr;26(4):379-85. doi: 10.1007/s11606-010-1511-x. Epub 2010 Sep 19. PMID 20853156
  • Collins AJ, Li S, Gilbertson DT, Liu J, Chen SC, Herzog CA. Chronic kidney disease and cardiovascular disease in the Medicare population. Kidney Int Suppl. 2003 Nov;(87):S24-31. doi: 10.1046/j.1523-1755.64.s87.5.x. PMID 14531770
  • Khan MS, Rashid AM, Shafi T, Rangaswami J, Cherney DZI, Butler J. Residual Risk of Adverse Kidney and Cardiovascular Outcomes in Patients with CKD. Clin J Am Soc Nephrol. 2025 Mar 1;20(3):451-454. doi: 10.2215/CJN.0000000588. Epub 2024 Dec 17. No abstract available. PMID 39688924
  • Perkovic V, Tuttle KR, Rossing P, Mahaffey KW, Mann JFE, Bakris G, Baeres FMM, Idorn T, Bosch-Traberg H, Lausvig NL, Pratley R; FLOW Trial Committees and Investigators. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024 Jul 11;391(2):109-121. doi: 10.1056/NEJMoa2403347. Epub 2024 May 24. PMID 38785209
  • Mayer GJ, Wanner C, Weir MR, Inzucchi SE, Koitka-Weber A, Hantel S, von Eynatten M, Zinman B, Cherney DZI. Analysis from the EMPA-REG OUTCOME(R) trial indicates empagliflozin may assist in preventing the progression of chronic kidney disease in patients with type 2 diabetes irrespective of medications that alter intrarenal hemodynamics. Kidney Int. 2019 Aug;96(2):489-504. doi: 10.1016/j.kint.2019. PMID 31142441
  • Neuen BL, Oshima M, Perkovic V, Agarwal R, Arnott C, Bakris G, Cannon CP, Charytan DM, Edwards R, Gorriz JL, Jardine MJ, Levin A, Neal B, De Nicola L, Pollock C, Rosenthal N, Wheeler DC, Mahaffey KW, Heerspink HJL. Effects of canagliflozin on serum potassium in people with diabetes and chronic kidney disease: the CREDENCE trial. Eur Heart J. 2021 Dec 21;42(48):4891-4901. doi: 10.1093/eurheartj/eha PMID 34423370
  • Brownell NK, Ziaeian B, Fonarow GC. The Gap to Fill: Rationale for Rapid Initiation and Optimal Titration of Comprehensive Disease-modifying Medical Therapy for Heart Failure with Reduced Ejection Fraction. Card Fail Rev. 2021 Nov 26;7:e18. doi: 10.15420/cfr.2021.18. eCollection 2021 Mar. PMID 34950508

Identifiers

NCT: NCT07547878 · 026-271

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗